Shaft and handle for a catheter with independently-deflectable segments

ABSTRACT

An elongate medical device with independently-deflectable segments and a handle for manually deflecting those segments can include a shaft having a distal segment and proximal segment, at least one proximal segment deflection wire adapted to deflect the proximal segment, at least one distal segment deflection wire adapted to deflect the distal segment independent of the proximal segment, and a handle portion. The handle portion may comprise a first manual actuation mechanism coupled to the at least one distal segment deflection wire and a second manual actuation mechanism coupled to the at least one proximal segment deflection wire. Actuation of the first manual actuation mechanism may impart a tensile force on the distal segment deflection wire to cause the distal segment to deflect, and actuation of the second manual actuation mechanism may impart a tensile force on the proximal segment to cause the proximal segment to deflect.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/032,020, filed 19 Sep. 2013, which is a divisional of U.S.application Ser. No. 13/406,152, filed 27 Feb. 2012, now pending (the'152 application), which is a continuation-in-part of U.S. applicationSer. No. 12/347,100, filed 31 Dec. 2008, now U.S. Pat. No. 8,123,721,issued 28 Feb. 2012 (the '100 application); and the '152 application isa continuation-in-part of U.S. application Ser. No. 13/105,646, filed 11May 2011, now pending (the '646 application), which claims the benefitof U.S. provisional application No. 61/333,641, filed May 11, 2010 (the'641 application). The '020 application, the '152 application, the '100application, the '646 application, and the '641 application are allhereby incorporated by reference as though fully set forth herein.

BACKGROUND OF THE INVENTION a. Field of the Invention

The instant disclosure relates to elongate medical devices.Specifically, the instant disclosure relates to the design andconstruction of elongate medical devices with independently-deflectableshaft segments and handles for deflecting those shaft segments.

b. Background Art

Catheters are used for an ever-growing number of procedures. Forexample, catheters are used for diagnostic, therapeutic, and ablativeprocedures, to name just a few examples. Typically, the catheter ismanipulated through the patient's vasculature and to the intended site,for example, a site within the patient's heart. The catheter typicallycarries one or more electrodes, which may be used for ablation,diagnosis, or the like.

To increase the ability to move and navigate a catheter within apatient's body, steerable catheters have been designed. Steerablecatheters are often manipulated by selectively tensioning one or morepull wires (or deflection wires) running along the length of thecatheter, typically offset from a central axis of the catheter, therebydeflecting the distal end of the steerable catheter in one or moreplanes. These pull wires are often attached to a metallic cathetercomponent located at the distal end of the catheter, such as one of theelectrodes carried on the distal end of the catheter or a pull ringincorporated in the catheter.

Steerable catheters often have a steering mechanism near the distal endof the catheter. This steering mechanism typically includes a pull ringand one or more pull wires (or deflection wires) attached thereto andextending proximally towards an actuator that can place the wire orwires in tension. Placing a pull wire in tension causes the distal endof the catheter to deflect in at least one plane. In this fashion, thecatheter can be navigated through the tortuous path of a patient'svasculature to a target site. Because of the length of the path that acatheter may need to travel to reach a target site, however,deflectability of only the distal end of the catheter may not providethe practitioner with as great a level of steerability as thepractitioner might desire.

In addition, once the catheter has been positioned at the target site,it often becomes necessary for the catheter to assume a particular shapein order to perform its desired function (e.g., a spiral shape forelectrophysiological mapping of the ostium of a pulmonary vein).Deflectability of only the distal end of the catheter may not providethe practitioner with the flexibility to deform the catheter into alldesirable shapes.

Like known catheter shafts, known control handles for controllingdeflection of catheter bodies have several drawbacks that adverselyimpact the handles' ability to be operated. First, the control handlesare often excessively bulky. Second, the control handles are ofteninadequate with respect to their ability to provide finely controlleddeflection adjustment for the distal end of the catheter body. Third,the control handles often provide inadequate deflection wire travel fora desired medical procedure. Fourth, the control handles often have amechanical advantage that is less than desirable and, as a result,require significant effort to operate on the part of a user. Fifth, oncea desired body distal end deflection has been reached, the controlhandles typically require the physician to take a conscious step tomaintain the catheter at the desired deflection. Sixth, the wiredisplacement mechanisms within the control handles have a tendency topermanently deform the deflection wires. Seventh, the wire displacementmechanisms within the control handles typically make it difficult, ifnot impossible, to provide a lumen that runs uninterrupted from theproximal end of the control handle to the distal end of the catheterbody.

There is therefore a need for a catheter that minimizes or eliminatesone or more of the problems set forth above.

BRIEF SUMMARY OF THE INVENTION

To address one or more of the problems set forth above, it may bedesirable to provide an elongate medical device withindependently-deflectable segments and a handle for manually deflectingthose segments. Such an elongate medical device may include a shafthaving a distal segment and proximal segment, at least one proximalsegment deflection wire adapted to deflect the proximal segment, atleast one distal segment deflection wire adapted to deflect the distalsegment independent of the proximal segment, and a handle portion. Thehandle portion may comprise a first manual actuation mechanism coupledto the at least one distal segment deflection wire and a second manualactuation mechanism coupled to the at least one proximal segmentdeflection wire. Actuation of the first manual actuation mechanism mayimpart a tensile force on the distal segment deflection wire to causethe distal segment to deflect, and actuation of the second manualactuation mechanism may impart a tensile force on the proximal segmentto cause the proximal segment to deflect.

In another embodiment, an elongate medical device may include a shaftcomprising a distal segment and a proximal segment, a distal segmentdeflection member configured to deflect the distal segment independentof said proximal segment, a proximal segment deflection memberconfigured to deflect the proximal segment, and a handle. The distalsegment deflection member may have a distal end coupled with the shaftdistal segment and a proximal end, and the proximal segment deflectionmember may have a distal end coupled with the shaft proximal segment anda proximal end. The handle may be coupled to the proximal segmentdeflection member proximal end and the distal segment deflection memberproximal end, and may be configured to control the deflection of theshaft proximal segment and the shaft distal segment.

An embodiment of a catheter shaft that may be used, for example, in oneor more of the embodiments above may include a proximal segment having aproximal segment wall and defining a proximal segment lumen and a distalsegment. The shaft can further include at least one deflection wirelumen extending through the proximal segment wall and at least oneproximal segment deflection wire configured to deflect the proximalsegment. Each of the at least one proximal segment deflection wire mayextend through a respective one of the at least one deflection wirelumen. The shaft can further include at least one distal segmentdeflection wire extending through the proximal segment lumen, the atleast one distal segment deflection wire configured to deflect thedistal segment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic view of a catheter being employed in a surgicalprocedure on a patient.

FIG. 2 is an isometric view of an embodiment of a catheter.

FIG. 3 is a longitudinal cross-sectional view of a an embodiment of acatheter body prior to the application of a reflow lamination process.

FIG. 4 is a cross-sectional view of a catheter body taken along line 4-4in FIG. 3.

FIG. 5 is the cross-sectional view of FIG. 4 after the application of areflow lamination process.

FIG. 6 is a simplified longitudinal cross-sectional view of anembodiment of a catheter body having independently-deflectable segments.

FIG. 7 depicts the catheter body of FIG. 6 with the distal segmentdeflected independent of the proximal segment.

FIG. 8 depicts the catheter body of FIG. 6 with the proximal segmentdeflected independent of the distal segment.

FIG. 9 depicts the catheter body of FIG. 6 with both the distal segmentand the proximal segment deflected such that the catheter body assumes apartial spiral configuration.

FIGS. 10A and 10B are partial cross-sectional views of, respectively, amanufacturing build-up that may be used to make an embodiment of acatheter body, and the finished embodiment.

FIG. 11 is a cross-sectional view of the catheter body of FIG. 10A,taken substantially along line 11-11, after a reflow lamination processand the removal of the center mandrel.

FIG. 12 is a cross-sectional view of the catheter body of FIG. 10A,taken substantially along line 12-12, after a reflow lamination processand the removal of the center mandrel.

FIG. 13 illustrates an embodiment of a pull ring.

FIG. 14 is a cross-sectional view of the pull ring of FIG. 13, takensubstantially along line 14-14.

FIG. 15 is an isometric view of an embodiment of a catheter.

FIG. 16 is an exploded isometric view of the catheter handle shown inFIG. 15.

FIG. 17 is a cross-sectional view of an embodiment of the handle of FIG.15 taken substantially along line 17-17 in FIG. 15.

FIG. 18 is an exploded view of the right and left slides of FIG. 17 withtheir respective deflection wires attached.

FIG. 19 is a cross-sectional view of an embodiment of a slide such asmay be used in the catheter handle of FIG. 16.

FIG. 20 is a cross-sectional view of the adjusting knob of the catheterof FIG. 15, taken substantially along line 20-20 in FIG. 15.

FIG. 21 is a cross-sectional view of an embodiment of the interior ofthe catheter handle of FIG. 15, taken substantially along line 21-21 ofFIG. 15.

FIG. 22 is a cross-sectional view of the slide of the catheter handle ofFIG. 21.

FIG. 23 is a cross-sectional view of an embodiment of the interior ofthe adjusting knob of the catheter handle of FIG. 15, takensubstantially along line 23-23 of FIG. 15.

FIG. 24 is a side view of an embodiment of a catheter handle.

FIG. 25 is a side view of the catheter handle depicted in FIG. 24.

FIG. 26 is an isometric view of the catheter handle depicted in FIG. 24.

FIG. 27 is a cross-sectional view of the catheter handle of FIG. 26,taken substantially along line 27-27 of FIG. 26.

FIG. 28 is a cross-sectional view of the adjusting knob of the catheterhandle of FIG. 26, taken substantially along line 28-28 in FIG. 26.

FIG. 29 is a right side isometric view of an embodiment of two slides,such as may be used in the catheter handle of FIG. 26, disposed about awire guide.

FIG. 30 is a left side isometric view of the slides of FIG. 29, disposedabout a wire guide.

FIG. 31 is a cross-sectional view of the handle grip of FIG. 24, takensubstantially along line 31-31 in FIG. 24.

FIG. 32 is a cross-sectional view of the handle grip of FIG. 25 takensubstantially along line 32-32 in FIG. 25.

FIG. 33 is an isometric view of an embodiment of a control handle for acatheter.

FIG. 34 is an isometric view of a portion of the interior of the controlhandle of FIG. 33.

FIG. 35 is a proximal end view of the interior shown in FIG. 34 asviewed from the perspective of arrow A in FIG. 34.

FIG. 36 is an isometric view of the distal end of the control handle ofFIG. 33.

FIG. 37 is an exploded view of an embodiment of a catheter controlhandle.

FIG. 38 is a cross-sectional view of the catheter control handle of FIG.37 taken substantially along line 38-38 in FIG. 37.

FIG. 39 is an isometric view of the slides of the handle of FIG. 37.

FIG. 40 is an exploded view of an embodiment of a catheter controlhandle.

FIG. 41 is a cross-sectional view of the catheter handle of FIG. 40,taken substantially along line 41-41 of FIG. 40.

FIG. 42 is a cross-sectional view of the adjusting knob of the catheterhandle of FIG. 40, taken substantially along line 42-42 of FIG. 40.

FIG. 43 is a side view of the slides of the catheter handle of FIG. 40.

FIGS. 44A and 44B are cross-sectional views of embodiments of a catheterhandle similar to the handle of FIG. 41, taken substantially along line44-44 in FIG. 41.

FIG. 45 is a side view of an embodiment of a wire guide equipped with agroove such as may be used in the catheter handle of FIG. 40.

FIG. 46 is a cross-sectional view of an embodiment of a catheter handlesimilar to the handle shown in FIG. 40, taken substantially along a linesimilar to line 46-46 of FIG. 40.

FIG. 47 is a cross-sectional view of the catheter handle of FIG. 46,taken substantially along a line similar to line 47-47 in FIG. 40.

FIG. 48 is an isometric view of an embodiment of a wire guide, such asmay be used with the catheter handle of FIG. 46.

FIG. 49 is a cross-sectional view of the catheter handle of FIG. 46,taken substantially along line 49-49 in FIG. 46.

FIG. 50 is an isometric view of an embodiment of a multi-directionalcatheter control handle.

FIG. 51 is an isometric view of a portion of the catheter handle of FIG.50.

FIG. 52 is an exploded view of the catheter handle of FIG. 50.

FIGS. 53-55 are top views of an embodiment of a multi-directionalcatheter control handle in various states of sub-assembly.

FIG. 56 is a top view of an embodiment of a multi-directional cathetercontrol handle in a state of sub-assembly where a wire guide is beinglocated within an adjusting knob insert.

FIG. 57 is an isometric view of an embodiment of a multi-directionalcatheter control handle with a grip removed.

FIG. 58 is an isometric view of an embodiment of a multi-directionalcatheter control handle with a grip and an adjusting knob removed.

FIGS. 59A-59E and FIGS. 60A-60E show respective side and top views of adistal portion of a partially-deflected catheter, sheath, medicaldevice, or other flexible elongate member.

FIGS. 61A-61E and FIGS. 62A-62E show respective side and top views of adistal portion of a more-fully-deflected catheter, sheath, medicaldevice, or other flexible elongate member.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the Figures, in which like reference numerals refer tothe same or similar features in the various views, FIG. 1 is adiagrammatic view of a patient 2 with a body lumen 4 providing access toa chamber 6 of a heart 8. FIG. 1 also shows an elongate medical device10 being used for a medical procedure on the heart 8. Throughout thisdisclosure, the terms elongate medical device, catheter, and flexibleelongate member are meant to be interchangeable except where notedotherwise and include, without limitation, catheters, sheaths, andsimilar medical devices. The elongate medical device 10 includes a shaft12 with a distal end 26 and a control handle 18 having an adjustmentknob 134. The shaft 12 can be inserted into the body of the patient 2intravenously via the body lumen 4, percutaneously, or via other avenuesfor entering the patient's body and guided through the body of thepatient 2 so that the distal end 26 can be disposed in the heart chamber6 to, for example only, perform an ablation procedure, mappingprocedure, or other treatment or diagnostic procedure. The shaft 12 mayinclude a number of features, such as deflection wires and pull rings,as will be detailed herein, to enable a physician to advance the distalend 26 of the elongate medical device 10 to an intended destination,such as a heart chamber 6, other portion of the heart 8, another organ,or another location in the body. The handle 18 may also include a numberof features for advancing and guiding the shaft 12, such as one or moreadjustment knobs 134, other external manual actuation mechanisms, andinternal components for translating force on an actuating mechanism intotension on a deflection wire. In an embodiment, the features of theelongate medical device 10 may allow for independent deflection of twosegments of catheter shaft 12, multi-directional deflection of thedistal end 26, or both.

It may be desirable to deflect a catheter shaft 12 in multipledirections and/or to deflect several segments of the shaft 12independently to improve guidance and positioning of the distal end 26for diagnostic and/or therapeutic procedures on a heart chamber 6 orother target. Accordingly, the present disclosure describes a number ofembodiments of a steerable or deflectable catheter suitable for use inthe human vasculature for known medical procedures, such as cardiacdiagnostic and therapeutic procedures including, without limitation,electrophysiological mapping and cardiac ablation. The disclosure firstwill describe, generally in conjunction with FIGS. 2-14, variousembodiments of a deflectable catheter shaft 12 that, in an embodiment,allow for independent deflection of two segments of the shaft 12, aswell as methods for manufacturing those shaft embodiments. Next,generally in conjunction with FIGS. 15-62, various embodiments of acontrol handle 18 for advancing and deflecting one or more cathetershaft segments will be described. Though generally described separately,the shaft embodiments of FIGS. 2-14 can be combined with appropriatehandle embodiments from FIGS. 15-62 to construct a catheter with adesired number and configuration of deflection wires and deflectablesegments.

FIG. 2 is an isometric view of an embodiment of a steerableelectrophysiology catheter 10 that includes an elongate catheter body orshaft 12 having a distal segment 14 and a proximal segment 16. Asdescribed in further detail below, distal segment 14 and proximalsegment 16 may be advantageously independently deflectable—that is,distal segment 14 can be deflected independent of proximal segment 16and vice-versa. This desirably imparts additional flexibility tocatheter 10, for example by permitting catheter 10 to be deflected intoconfigurations that would not otherwise be attainable. A handle 18 maybe coupled to a proximal end 20 of catheter body 12 to control catheter10, for example to control the deflection of distal segment 14 andproximal segment 16.

A plurality of electrodes, such as tip electrode 22 and ring electrodes24, may be located near the distal end 26 of catheter body 12, forexample within distal segment 14 as illustrated. Of course, it is withinthe scope of the present invention for electrodes to be present withinproximal segment 16 in addition to or instead of within distal segment14. By way of example only, electrodes 22, 24 may be used to deliverablating energy to a tissue surface during an ablation procedure, forexample to treat atrial fibrillation, or to measure electrophysiologicalcharacteristics during a diagnostic procedure, for example to mapconduction pathways on a patient's heart. One of ordinary skill in theart will appreciate how to attach electrodes 22, 24 to catheter body 12.

One suitable method of manufacturing catheter body 12 will be describedwith reference to FIGS. 3-5. As they are assembled, the cathetercomponents will be collectively referred to as a “catheter assembly.”

FIG. 3 is a longitudinal cross-sectional view of a catheter assemblyprior to the application of heat to melt process the outer layer. Asdepicted in FIG. 3, a mandrel 30, which may be round in cross-section,is a component of catheter assembly 32, and may be the first componentthereof during manufacture of catheter body 12. An inner layer 34 isplaced on mandrel 30. Inner layer 34 may be knotted at one end (e.g.,the distal end) and then fed onto mandrel 30. Of course, mandrel 30 andinner layer 34 may have any shape consistent with the desired finallumen configuration and/or intended use of catheter 10.

Mandrel 30 has a distal segment 30 a and a proximal segment 30 b.Likewise, inner layer 34 has a distal segment 34 a and a proximalsegment 34 b. For the sake of illustration only, distal segments 30 a,34 a and proximal segments 30 b, 34 b are shown as divided by a dashedvertical line. The actual location of the division between distalsegments 30 a, 34 a and proximal segments 30 b, 34 b can be varied asdesired for a particular configuration and/or intended use of catheter10. For example, the distal segment can be made longer than the proximalsegment if a higher degree of deflection is desired in the distalsegment than in the proximal segment. Alternatively, the distal segmentcan be made shorter than the proximal segment if a higher degree ofdeflection is desired in the proximal segment than in the distalsegment.

In an embodiment of the invention, inner layer 34 is an extrudedpolytetrafluoroethylene (PTFE) tubing, such as TEFLON® brand tubing,which is available commercially. In other forms, inner layer 34 may bemade of other melt processing polymers, including, without limitation,etched polytetrafluoroethylene, polyether block amides, nylon, and otherthermoplastic elastomers. One such elastomer is PEBAX®, made by Arkema,Inc. PEBAX® of various durometers may be used, including, withoutlimitation, PEBAX® 30D to PEBAX® 70D. According to one aspect of theinvention, inner layer 34 is made of a material with a meltingtemperature higher than that of an outer layer, which will be furtherdescribed below, such that inner layer 34 will withstand melt processingof the outer layer.

A distal segment steering mechanism may then be formed about distalsegment 34 a of inner layer 34. In some embodiments, the distal segmentsteering mechanism will include at least one distal segment pull ring 36to which one or more distal segment deflection wires may be attached.One of ordinary skill in the art will appreciate that these deflectionwires may be connected to distal segment pull ring 36 prior to or aftermelt processing of catheter assembly 32. In some embodiments of theinvention, the distal segment deflection wires are attached after meltprocessing of catheter assembly 32.

Optionally, a first wire reinforcing layer 38 may be formed over innerlayer 34, and optionally also about the distal segment steeringmechanism (e.g., distal segment pull ring 36). It is contemplated thatfirst wire reinforcing layer 38 may be a braided wire assembly formedabout distal segment 34 a and at least a portion of proximal segment 34b of inner layer 34 that serves to both reinforce catheter body 12 andto transmit torque along the length of catheter body 12. Such anassembly may be formed of stainless steel wire, including for example0.003″ high tensile stainless steel wire, and may be formed in astandard braid pattern and density, for example, about 16 wires at about45 to about 60 picks per inch (“PPI”) density. Alternatively, a braidmay be used that is characterized by a varying braid density. Forexample, the braided wire assembly may be characterized by a braiddensity that varies along the length of inner layer 34. The braiddensity nearer distal end 26 of catheter body 12 may be greater or lessthan the braid density at more proximal locations along catheter body12. As but one example, the braid density near distal end 26 of catheterbody 12 may be about 10 PPI, while the braid density at more proximallocations may be as high as about 50 PPI. As another example, the braiddensity near distal end 26 may be about 20% to about 35% of the braiddensity at more proximal locations. One of ordinary skill in the artwill appreciate how to select a suitable braided wire assembly for aparticular application of catheter 10.

First wire reinforcing layer 38 may be formed separately on a disposablecore. One or more portions of first wire reinforcing layer 38 may beheat tempered and cooled before incorporation into catheter assembly 32though methods that are known to those of ordinary skill in the art. Theaction of heat tempering may help to release the stress on the wire andhelp reduce radial forces. It is also contemplated that first wirereinforcing layer 38 may be formed directly on catheter assembly 32, forexample by passing catheter assembly 32 through a braiding machineduring assembly thereof. In still other embodiments, distal segment pullring 36 is formed about first wire reinforcing layer 38.

A proximal segment steering mechanism may then be formed about proximalsegment 34 b of inner layer 34. In some embodiments, the proximalsegment steering mechanism will include at least one proximal segmentpull ring 40 to which one or more proximal segment deflection wires maybe attached. Like the distal segment deflection wires described above inconnection with the distal segment steering mechanism, one of ordinaryskill in the art will appreciate that these deflection wires may beconnected to proximal segment pull ring 40 prior to or after meltprocessing of catheter assembly 32. In some embodiments of theinvention, the proximal segment deflection wires are attached after meltprocessing of catheter assembly 32. Of course, proximal segment pullring 40 may be formed directly about proximal segment 34 b of innerlayer 34 (as shown in FIG. 3) or about a more proximal portion of firstwire reinforcing layer 38.

Optionally, a second wire reinforcing layer 42 may be formed over innerlayer 34, and, in some aspects of the invention, also about the proximalsegment steering mechanism (e.g., proximal segment pull ring 40). Incertain embodiments, second wire reinforcing layer 42 is a braided wireassembly formed about proximal segment 34 b and at least a portion ofdistal segment 34 a of inner layer 34 that serves to both reinforcecatheter body 12 and to transmit torque along the length of catheterbody 12. In some embodiments of the invention, first and second wirereinforcing layers 38, 42 overlap adjacent the boundary between distalsegment 34 a and proximal segment 34 b of inner layer 34. Thedescription of first wire reinforcing layer 38 herein (e.g., suitablematerials, braid densities, and the like) applies to second wirereinforcing layer 42 as well.

An outer layer 44 is then placed over catheter assembly 32 (e.g., innerlayer 34; first and second wire reinforcing layers 38, 42 (if present);distal segment pull ring 36; and proximal segment pull ring 40).According to some aspects of the invention, outer layer 44 is made ofone or more polymeric materials, such as any of the polymeric materialsdescribed above in connection with inner layer 34. Outer layer 44 may bemade of either single or multiple sections or segments of tubing thatmay be either butted together or overlapped with each other, and thesections may vary in hardness and in length as desired for a particularapplication or intended function of catheter 10. For example, thehardness of outer layer 44 may decrease distally or proximally, or mayprovide a segment of increased hardness between two segments of lesserhardness. The various segments will be bonded together in subsequentprocessing, resulting in a catheter body that has longitudinally varyingstiffness, which may be desirable in certain applications of catheter10.

It is also contemplated for outer layer 44 to include more than oneconcentrically-arranged layer, for example two or more layers ofmelt-processing polymeric material, which may vary radially in hardness.That is, a first, inner layer of outer layer 44 may have a firsthardness, while a second, outer layer of outer layer 44 may have asecond hardness. If a radially-varying outer layer 44 is utilized, thesecond, outer layer of outer layer 44 may have a lower hardness than thefirst, inner layer of outer layer 44 to facilitate an atraumaticcatheter body 12.

FIG. 4 depicts a cross-section of catheter assembly 32 taken along line4-4 in FIG. 3 before lamination of the materials by heating. In oneembodiment, a layer of heat shrink 46 is placed over the top of outerlayer 44 prior to lamination. Heat shrink 46 may be a fluoropolymer orpolyolefin material.

FIG. 5 depicts catheter assembly 32 after a lamination process. Catheterassembly 32 may be laminated by heating catheter assembly 32 until thematerial comprising outer layer 44 flows and redistributes around thecircumference thereof as depicted in FIG. 5. Heat shrink 46 has a highermelting temperature than outer layer 44. During the melt process, heatshrink 46 retains its tubular shape and forces the liquefied outer layer44 material into first and second wire reinforcing layers 38, 42 (ifpresent), around distal segment pull ring 36 and proximal segment pullring 40 (e.g., as described below), and into contact with inner layer34. Catheter assembly 32 may then be cooled.

Mandrel 30 may be removed from catheter assembly 32, leaving behind alumen 48 as illustrated in FIG. 5, which depicts a catheter body 12 madein accordance with the method described above subsequent to theapplication of heat for the lamination process. Optionally, heat shrink46 may be left in place around outer layer 44 even after mandrel 30 isremoved, such that heat shrink 46 becomes the outermost layer ofcatheter body 12. If heat shrink 46 is removed, outer layer 44 becomesthe outermost layer of catheter body 12. The result is a substantiallycircular and unitary catheter body 12 with a generally circular centrallumen 48. First and second wire reinforcing layers 38, 42, distalsegment pull ring 36, and proximal segment pull ring 40 aresubstantially embedded within outer layer 44 material as illustrated inFIG. 4.

As shown in FIG. 6, at least one proximal segment deflection wire 50 andat least one distal segment deflection wire 52 may then be placed intocatheter body 12 and attached, respectively, to proximal segment pullring 40 and distal segment pull ring 36 (if not placed prior tolamination of catheter assembly 32). As with FIG. 3, FIG. 6 shows adashed vertical line separating distal segment 14 and proximal segment16 for the sake of illustration. In addition, for the sake of clarity,first and second wire reinforcing layers 38, 42 are not shown in FIG. 6and the laminated combination of inner layer 34 and outer layer 44 isshown as a substantially unitary wall 54.

In the embodiment depicted in FIG. 6, a pair of distal segmentdeflection wires 52 are connected to distal segment pull ring 36 andextend proximally (e.g., towards handle 18, not shown in FIG. 6). Withinat least part of proximal segment 16 of catheter shaft 12, distalsegment deflection wires 52 extend through lumen 48. As depicted, distalsegment deflection wires enter wall 54 within proximal segment 16 andextend through wall 54 within distal segment 14, where they terminate ata connection to distal segment pull ring 36. Routing distal segmentdeflection wires 52 through lumen 48 in at least part of proximalsegment 16 is desirable in that it reduces the complexity of wall 54within proximal segment 16. Of course, it is within the scope of theinvention for distal segment deflection wires 52 to enter wall 54 at amore proximal location than that depicted in FIG. 6, including extendingentirely through wall 54 within proximal segment 16. Distal segmentdeflection wires 52 are adapted to deflect distal segment 14 in at leastone plane independent of proximal segment 16 when placed in tension. Asillustrated, distal segment deflection wires 52 will deflect distalsegment 14 upward and downward (as shown FIGS. 7 and 9).

A pair of proximal segment deflection wires 50 are connected to proximalsegment pull ring 40 and extend proximally (e.g., towards handle 18, notshown in FIG. 6). As depicted, proximal segment deflection wires 50extend entirely through wall 54. It is contemplated, however, thatproximal segment deflection wires 50 may also extend at least partiallythrough lumen 48. Proximal segment deflection wires 50 are adapted todeflect proximal segment 16 in at least one plane independent of distalsegment 14 (i.e., independent of deflection caused by distal segmentdeflection wires 52) when placed in tension. As illustrated, proximalsegment deflection wires 50 will deflect proximal segment 16 upward anddownward (as shown in FIGS. 8 and 9).

Deflection wires 50, 52 may have any desired cross-section, such ascircular, flat, elliptical, or any other shape. For example, a flat wiremay be used when it is desirable for the resultant catheter to favordeflection along one axis and yet be predisposed to resist deflectionalong a second, generally orthogonal axis. Flat wires may also beemployed to good advantage where it is desirable to have a low-profile(e.g., thin) wall for the resultant catheter, thereby to maximize thesize of lumen 48 relative to the overall size of the catheter.

Any or all of deflection wires 50, 52 may also be a shape memory alloywire, such as a wire containing nickel and titanium (known commerciallyas NiTi or Nitinol); copper, aluminum, and nickel; or copper, zinc, andaluminum. The shape memory effect facilitates returning distal segment14 and proximal segment 16 of catheter body 12 to their original,undeflected (“home”) positions when wires 50, 52 are unloaded (e.g., notplaced in tension via a suitable actuator (not shown) or manualactuation mechanism on handle 18 of catheter 10).

In alternative embodiments, wires 50, 52 may be covered with lubriciousmaterials including silicone, TEFLON®, siloxane, and other lubriciousmaterials before placement. Alternatively, wires 50, 52 may also becoated with a lubricious layer to promote slideability. It is alsocontemplated that wires 50, 52 may be manufactured with a smooth surfaceto promote slideability. Wires 50, 52 may also be disposed in tubes witha lubricous inner lining, as shown in the embodiment of FIGS. 10A-12.

FIG. 9 depicts the catheter body of FIG. 6 with both distal segment 14and proximal segment 16 deflected, illustrating the advantageousflexibility of a catheter shaft constructed according to the presentinvention. One advantage of the present invention is that it allowscatheter 10 to be introduced and navigated through a patient'svasculature in one configuration (e.g., a substantially straightconfiguration) and then conveniently deflected into a secondconfiguration upon reaching a target site. One of ordinary skill in theart will appreciate that, by providing additional deflection wiresand/or by changing the location of distal segment pull ring 36 and/orproximal segment pull ring 40, distal end 26 of catheter body 12 can besteered through a patient's vasculature to a target site and then formedinto any number of shapes. Examples of such shapes include spirals andC-shaped curves, both of which may be desirable in the creation ofpulmonary vein isolation lesions.

FIGS. 10A-12 illustrate a second embodiment of a catheter shaft havingindependently-deflectable segments and a method for manufacturing theshaft. The embodiment illustrated in FIGS. 10A-12 may be referred to asa “catheter-on-catheter” assembly because its manufacture involvesadding a proximal shaft segment to a completed distal shaft segment, aswill be further described below. The embodiment shown in FIGS. 10A-12can be used with an appropriate handle such as the embodiment shown inFIGS. 50-58.

FIG. 10A is a partial cross-sectional side view, with portions cut away,of a catheter assembly 56 in an intermediate stage of build-up for a“catheter-on-catheter” construction. The catheter assembly 56 includes aproximal segment 58 and a distal segment 60, which will respectivelybecome proximal and distal segments of a finished catheter shaft after areflow lamination process, disposed on a grooved mandrel 64 (shown inpartial cross-section). For the sake of illustration only, proximalsegment 58 and distal segment 60 are shown as divided by a dashedvertical line. The distal segment 60 includes a shaft 62 (shown inpartial cross-section), a distal pull ring 66 embedded in the shaft 62,and two pull wires (shown in FIG. 11), also embedded in the shaft 62.The proximal segment 58 includes a proximal pull ring 68 (shown inpartial cross-section), proximal pull wires 70, and an outer layer 72(shown in partial cross-section).

The construction of a “catheter-on-catheter” assembly may begin with themanufacture of the inner catheter—i.e., the catheter shaft 62 formingdistal segment 60. The catheter shaft 62 may be manufactured accordingto a method similar to that described above in conjunction with FIGS.2-9, or by another method known in the art. Accordingly, the distalsegment 60 may include other features not shown in FIG. 10A, such as awire braid reinforcing layer, one or more electrodes (e.g., sensing orablation electrodes) or other sensors, or other features known in theart.

The catheter shaft 62 also includes, as noted above, distal segment pullwires (shown in FIGS. 11 and 12). The distal segment pull wires may beembedded in a portion of the wall of the shaft 62 to extend from thedistal pull ring 66 proximally through the wall of the shaft 62. At apoint proximal of the distal pull ring 66, the distal deflection wiresmay transition through the wall of the shaft 62 and extend proximallythrough the center lumen of the shaft, similar to the configurationshown in FIGS. 6-9, for connection to a catheter handle at the proximalend of the finished shaft.

The grooved mandrel 64 may be placed through the center of finishedcatheter shaft 62. If the distal segment deflection wires extend throughthe center lumen of the shaft 62 (i.e., are not entirely embedded withinthe wall of the shaft 62), they may be threaded into grooves in themandrel 64 so that the distal deflection wires do not become embedded inthe wall of the proximal segment 58 during reflow lamination.

After the shaft 62 is placed on the mandrel 64, the proximal pull ring68 may be placed about the shaft 62. As noted above, the deflected shapeof the completed shaft can be affected by the positions of the proximaland distal pull rings. Accordingly, the axial location for the proximalpull ring 68 may be selected according to the desired deflectionposition of the proximal segment.

Proximal pull wires 70 may be placed over the shaft 62 and coupled tothe proximal pull ring 68 by, for example only, welding. The proximalpull wires 70 may be placed in respective protective sheaths (shown inFIG. 12) so that the pull wires 70 do not become immovably embedded inthe proximal segment 58 during reflow lamination. Each protective sheathmay be lined on its interior surface with a lubricous material, such asTEFLON®, to allow the pull wires 70 to slide within the sheath withminimal friction. The proximal pull wires 70 (i.e., the protectivesheaths) may also be bonded to the shaft 62 with adhesive or anothermeans known in the art so that the proximal pull wires do not shiftposition during reflow lamination. The proximal pull wires 70 may beextended proximally through the assembly for connection to anappropriate handle. In an embodiment, the proximal pull wires 70 may beconnected to the same handle as the distal pull wires. An embodiment ofan appropriate handle for such a configuration is shown in FIGS. 50-58.

An outer layer 72 may be placed on top of and about the shaft 62, theproximal pull ring 68, and the proximal pull wires 70. The outer layer72 may include an extruded PTFE tubing, such as TEFLON® brand tubing,which is available commercially. In other forms, the outer layer 72 maybe made of other melt processing polymers, including, withoutlimitation, etched polytetrafluoroethylene, polyether block amides,nylon, and other thermoplastic elastomers. One such elastomer is PEBAX®,made by Arkema, Inc. PEBAX® of various durometers may be used,including, without limitation, PEBAX® 30D to PEBAX® 70D.

The outer layer 72 may be made of either single or multiple sections orsegments of tubing that may be either butted together or overlapped witheach other, and the sections may vary in hardness and in length asdesired for a particular application or intended function of thecompleted catheter. For example, the hardness of the outer layer 72 maydecrease distally or proximally, or may provide a segment of increasedhardness between two segments of lesser hardness. The outer layer 72 mayalso include more than one concentrically-arranged layer, for exampletwo or more layers of melt-processing polymeric material, which may varyradially in hardness. That is, a first, inner layer of outer layer 72may have a first hardness, while a second, outer layer of outer layer 72may have a second hardness. If a radially-varying outer layer 72 isutilized, the second, outer layer of outer layer 72 may have a lowerhardness than the first, inner layer of outer layer 72 to facilitate anatraumatic catheter body.

FIG. 10B is a cross-sectional view of catheter 56 of FIG. 10A in afurther stage of manufacture, with portions broken away. In theillustrated embodiment, a distal tip RF ablation electrode 75 isincorporated into the catheter assembly 56. To complete the manufactureof the catheter-on-catheter assembly, a layer of heat shrink 73 may beplaced about the proximal catheter assembly 56, and catheter assembly 56may be exposed a reflow lamination process. During reflow, the outerlayer 72 and the shaft 62 may melt and flow together to form a unitaryshaft in which the proximal pull ring 68 and the proximal pull wires 70can be embedded. However, depending on the properties of outer layer 72and shaft 62 (e.g., the respective melting points of their materials),outer layer 72 and shaft 62 may remain distinguishable from, thoughaffixed to, each other after reflow lamination. In an alternateembodiment, the heat shrink 73 may be placed only around the proximalsegment 58, and only the proximal segment 58 can be exposed to reflowlamination.

Either before or after reflow lamination, one or more sensor andelectrodes, such as the distal tip electrode 75, can be added to thecatheter assembly 56. The distal tip electrode 75, along with any othersensors and electrodes included in the catheter assembly 56, can be usedfor diagnostic and/or therapeutic procedures such as, for example only,an RF ablation procedure. The distal tip electrode 75 can be joined tothe catheter assembly 56 through a means known in the art such as, forexample only, an adhesive.

FIG. 11 is a cross-sectional view of the distal segment 60 of thecatheter assembly shown in FIG. 10A after the removal of the mandrel 64.The distal segment includes a shaft 62 defining a center lumen 74, andtwo distal pull wire assemblies 76, each of which includes a pull wire78 and a protective sheath 80. Each pull wire assembly 76 is embedded inthe wall of the shaft 62, i.e., disposed between the inner diameterID_(d) and outer diameter OD_(d) of the shaft 62. Within the wall of theshaft 62, each sheath 80 defines a deflection wire lumen for a distalsegment deflection wire 78.

FIG. 12 is a cross-sectional view of the proximal segment 58 of thecatheter assembly shown in FIG. 10A after a reflow lamination processand the removal of the mandrel 64. After reflow, the proximal segment 58includes an outer shaft portion 82, an inner shaft 62, two proximaldeflection wire assemblies 84, each of which includes a protectivesheath 86 and a deflection wire 88, and two distal deflection wireassemblies 78, each including a deflection wire 78 and a protectivesheath 80, extending through the center lumen 74. Within the wall of theouter shaft portion 82, each sheath 86 defines a deflection wire lumenfor a proximal segment deflection wire 88.

As noted above, the shaft 62 and outer layer 72 may reflow together intoa unitary shaft, in an embodiment, or may remain separately identifiable(though affixed) layers after reflow, in another embodiment. FIG. 12illustrates the latter. Accordingly, the outer shaft portion 82 mayinclude material both from shaft 62 and outer layer 72, or may compriseonly material from outer layer 72, as shown. In either embodiment, outershaft portion 82 may add an identifiable thickness t to the catheterassembly 56 between an inner diameter ID_(p) and an outer diameterOD_(p) of the outer shaft portion 82.

A practical consequence of a catheter-on-catheter construction is thatthe outer diameter of the proximal segment OD_(p) may be larger than theouter diameter of the distal segment OD_(d). Accordingly, in anembodiment, it may be desirable to minimize the radial thickness t ofthe outer shaft portion 82 to minimize the total radial size (i.e., theouter diameter OD_(p)) of the proximal segment 58. One way that thethickness t of the outer shaft portion 82 can be minimized, as shown inFIGS. 10A-12, is by routing the distal segment deflection wireassemblies 76 through the lumen 74 of the proximal segment 58, ratherthan through the wall formed by outer shaft portion 82. In such anembodiment, the inner diameter ID_(p) of the outer shaft portion 82(which may also be the outer diameter of the distal segment 60) may beabout 0.090 inches, the thickness t of the outer shaft portion 82 may beabout 0.013-0.014 inches, and the outer diameter ODp of the outer shaftportion 82 may be about 0.116-0.118 inches. In addition, the diameter ofthe proximal deflection wire sheath 86 may be about 0.009 inches.

The proximal segment deflection wires 88 and distal segment deflectionwires 78 can have a number of different shapes (i.e., in cross-sectiontaken transverse to the central axis of the wire). The deflection wires78, 88 can be substantially circular in cross-section, as shown in FIGS.11 and 12, or can be “flat” with a substantially rectangularcross-section, or can have some other shape. Flat deflection wires maybe used to reduce the outer diameter of the proximal segment 58 evenfurther. In an embodiment, a flat deflection wire may have dimensions ofabout 0.012 inches wide by 0.004-0.006 inches thick.

FIGS. 13 and 14 illustrate a suitable pull ring 90 that may be employedas a distal segment pull ring 36, 66 and/or proximal segment pull ring40, 68. The pull ring 90 is a generally circular band with across-sectional shape (measured orthogonally to a tangential linerelative to the circle of the band) that is substantially rectangular.The rectangular cross-section is more clearly depicted in FIG. 14. Theinner and outer dimensions of the pull ring 90 may be determined basedon the application of the catheter being manufactured.

The pull ring 90 may have at least one slot 92 configured to accommodatea flat deflection wire (e.g., an embodiment of proximal segmentdeflection wire 78 ₁ or distal segment deflection wire 88 ₁). Wire 78 ₁,88 ₁ may be secured within slot 92 by any technique that is appropriategiven the materials of pull ring 90 and wire 78 ₁, 88 ₁. Acceptabletechniques include, but are not limited to, soldering, brazing, laserwelding and/or other welding and metallurgical bonding techniques.

Pull ring 90 may also contain one or more flow holes 96. During meltprocessing of catheter assembly 32, 56, the material of outer layer 44,72 melts and flows through flow holes 96. Upon cooling, the material ofouter layer 44, 72 bonds to pull ring 90 to provide better adhesionbetween pull ring 90 and the remaining components of catheter assembly32, 56, thereby improving performance of the finished catheter. Whilethe flow holes 96 are depicted as circular, other shapes may be used.The size, shape, and position of the flow holes 96 may be adjusted basedon the materials being used to form inner layer 34 (or shaft 62) and/orouter layer 44, 72.

The pull ring may also be utilized with non-flat deflection wires. Apull ring according to this embodiment may be a circular band with across-sectional shape (measured orthogonally to a tangential linerelative to the circle of the band) that is substantially rectangular.Such a pull ring may have at least one slot that is configured toaccommodate a non-flat deflection wire (such as a round wire, e.g.,deflection wires 78, 88). The tip of the non-flat deflection wire may betapered to facilitate joinder with the pull ring. The non-flatdeflection wire may be secured within the slot by any technique that isappropriate given the materials of the pull ring and the deflectionwires.

Although several embodiments of a catheter shaft have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this invention. For example,though both the first and second wire reinforcing layers are describedherein as braided wire assemblies, one of ordinary skill in the art willappreciate that other configurations of the first and second wirereinforcing layers, such as opposing helically-wound wire coils, mayalso be utilized to good advantage in the present invention.

As another example, though only two deflection wires spacedapproximately 180 degrees apart in each of the proximal segment and thedistal segment are shown and described above, it is contemplated thatany number of deflection wires may be utilized. For example, each of theproximal segment and the distal segment may have four deflection wiresspaced approximately 90 degrees apart.

In addition, some or all of the deflection wires may be attacheddirectly to the wall of the catheter or to another metallic component ofthe catheter (e.g., a tip electrode) rather than to dedicated pull ringsembedded in the wall of the catheter.

It is also contemplated that a catheter shaft 12 may be manufacturedusing techniques other than those described herein. For example, in someembodiments, an outer layer may be formed by extruding the outer layerover the rest of the catheter assembly. In other embodiments, thecatheter assembly may be formed by using a combination of heat and apress that has a mold for defining the final shape of the cathetershaft.

One of ordinary skill in the art will also appreciate that a catheterassembly may also be provided with various tips, electrodes, and thelike suitable for a particular application of a catheter either beforeor after reflow lamination (i.e., melt processing).

A catheter shaft manufactured according to the embodiments and methodsdescribed above can be combined with an appropriate handle forseparately manipulating the proximal and distal segments of the cathetershaft. Embodiments of such a handle—i.e., a handle for separatelymanipulating two sets of two deflection wires each—will be discussed inconjunction with FIGS. 50-62. First, in conjunction with FIGS. 15-49,the operation of various embodiments of a handle configured forindependently manipulating a single pair of deflection wires will firstbe discussed to more generally illustrate various aspects of a cathetercontrol handle.

FIG. 15 is an isometric view of an embodiment of a catheter 110 having acontrol handle 118 and a flexible tubular body 112 having a proximalsegment 116, a distal segment 114, and a distal end 126. As shown inFIG. 15, in one embodiment, the distal end of the handle 118 isconnected to the catheter body 112 and the proximal end of the handle118 is connected to tubing 130 that contains electrical wire and extendsto an electrical connector 132. The handle 118 includes an adjustingknob 134 and a handle grip 136. As will become clear from thisspecification, the handle 118 of the present invention is advantageousin that it is compact and allows a user to manipulate the catheterbody's extreme distal end 126 in a bi-directional manner by pivoting theadjusting knob 134 relative to the handle grip 136 in one direction orthe other about the longitudinal axis of the handle 118. Furthermore, inone embodiment, the handle 118 has a lumen that runs uninterrupted fromthe proximal end of the handle 118 to the extreme distal end 126 of thecatheter body 112. This lumen can be used, for example only, to providecontrast injection for guide wire insertion.

For a more detailed discussion of the handle 118, reference is now madeto FIGS. 16 and 17. FIG. 16 is an exploded isometric view of the handle118 to show the various components of the handle 118. FIG. 17 is across-sectional view of the handle 118 taken along section line 17-17 ofFIG. 15.

As shown in FIGS. 16 and 17, the adjusting knob 134 is pivotallyattached to a mounting shaft (i.e., a slide base or base portion) 138contained within the handle grip 136. To pivotally attach the knob 134to the mounting shaft 138, a dowel pin 140 is inserted into a pinhole142 in the distal end of the shaft 138 and mates with a groove 144 in ahub portion 146 of the knob 134. A silicone o-ring 148 exists betweenthe hub portion 146 of the knob 134 and the distal end of the shaft 138.

As indicated in FIGS. 16 and 17, a wire guide 150 is positioned withinthe adjusting knob 134 and is held in place by a retaining ring 152. Aright slide or member 154 and a left slide or member 156 are slideablypositioned within a slot (i.e., a slide compartment) 158 in the mountingshaft 138. A catheter body-retaining nut 160 is used to secure thecatheter body 112 to the distal end of the wire guide 150.

As illustrated in FIG. 17, a pair of deflection wires 162 extend fromthe extreme distal end 126 of the body 112, through the body 112, thewire guide 150 and a passage 164 formed between the two slides 154, 156,to a point near a proximal portion of the slides 154, 156. Each wire 162then affixes to an individual slide 154, 156 via a retention screw 166.

For a more detailed discussion of the slides 154, 156 and theirrelationship to the deflection wires 162, reference is now made to FIG.18, which is an isometric view of the deflection wires 162 a, 162 battached to the right and left slides 154, 156. As shown in FIG. 18, theslides 154, 156, which are mirror images of each other, each have arectangular box-like proximal portion 168 and a half-cylinder distalportion 172. Each proximal portion 168 has a generally planar outersidewall and bottom wall. These planar surfaces slideably displaceagainst the generally planar sides and bottom of the slot 158, which actas thrust surfaces for the slides 154, 156.

Each half-cylinder distal portion 172 is hollowed out along itslongitudinal axis to form the passage 164 through which the deflectionwires 162 a, 162 b and, as indicated in FIG. 18, the narrow proximalportion of the wire guide 150 extends when the slides 154, 156 are inthe assembled handle 118. Each slide 154, 156 has a planar slide face174 that is meant to slideably abut against the planar slide face 174 ofthe opposing slide 154, 156. Thus, as illustrated in FIG. 18, when theplanar slide faces 174 of the slides 154, 156 abut against each otherand the extreme proximal ends of each slide 154, 156 are flush with eachother, the half-cylinder distal portions 172 of each slide 154, 156combine to form a complete cylinder with a channel or passage 164 therethrough.

As shown in FIG. 18, in one embodiment, the proximal end of eachdeflection wire 162 a, 162 b forms a loop 176 through which a retentionscrew 166 passes to secure the wire 162 a, 162 b to the proximal portionof the respective slide 154, 156. As indicated in FIG. 19, which is aside elevation of an exemplary slide 154, in one embodiment, theproximal end of each deflection wire 162 forms a knot 178. The wire 162passes through a hollow tension adjustment screw 180 and the knot 178abuts against the head 182 of the screw 180, thereby preventing the wire162 from being pulled back through the screw 180. In one embodiment, thescrew's longitudinal axis and the longitudinal axis of the slide 154,156 are generally parallel. Each tension adjustment screw 180 isthreadably received in the proximal end of its respective slide 154,156. Tension in a wire 162 may be increased by outwardly threading thewire's tension adjustment screw 180. Conversely, tension in a wire 162may be decreased by inwardly threading the wire's tension adjustmentscrew 180.

As can be understood from FIG. 18, in one embodiment where the wires 162a, 162 b are intended to only transmit tension forces, the wires 162 a,162 b may deflect or flex within an open area 170 defined in theproximal portion 168 of each slide 154, 156 when the slides 154, 156displace distally. Similarly, as can be understood from FIG. 19, inanother embodiment where the wires 162 are intended to only transmittension forces, the wires 162 may slide proximally relative to the screw180 when the slides 154, 156 displace distally.

As shown in FIG. 18, in one embodiment, the outer circumference of thehalf-cylinder distal portion 172 of the right slide 154 is threaded witha right-hand thread 184, and the outer circumference of thehalf-cylinder distal portion 172 of the left slide 156 is threaded witha left-hand thread 186. In one embodiment, the outer circumference ofthe half-cylinder distal portion 172 of the right slide 154 is threadedwith a left-hand thread, and the outer circumference of thehalf-cylinder distal portion 172 of the left slide 156 is threaded witha right-hand thread.

For a better understanding of the relationship of the slide threads 184,186 to the rest of the handle 118, reference is now made to FIG. 20,which is a longitudinal sectional elevation of the adjusting knob 134taken along section line 20-20 of FIG. 15. As indicated in FIG. 20, acylindrical hole or shaft 188 passes through the knob 134 along theknob's longitudinal axis. In the hub portion 146 of the knob 134, theinner circumferential surface of the shaft 188 has both right handthreads 190 and left hand threads 192. These internal threads 190, 192of the knob 134 mate with the corresponding external threads 184, 186 ofthe slides 154, 156. More specifically, the right internal threads 190of the knob 134 mate with the right external threads 184 of the rightslide 154, and the left internal threads 192 of the knob 134 mate withthe left external threads 186 of the left slide 156.

Thus, as can be understood from FIGS. 16, 17, 18, and 20, in oneembodiment, as the knob 134 is rotated clockwise relative to thelongitudinal axis of the handle 118, the internal and external rightthreads 190, 184 engage and the internal and external left threads 192,186 engage, thereby causing simultaneous opposed displacement of theright and left slides 154, 156 longitudinally within the slot 158 in thehandle 118. Specifically, because of the threading arrangement of theknob 134 and the slides, 154, 156, the right slide 154 moves distallywithin the slot 158 and the left slide 156 moves proximally within theslot 158 when the knob 134 is rotated clockwise relative to the handlegrip 136 of the handle 118. Conversely, when the knob 134 is rotated ina counterclockwise manner relative to the handle grip 136 of the handle118, the right slide 154 moves proximally within the slot 158 and theleft slide 156 moves distally within the slot 158.

As can be understood from FIGS. 18 and 20, when the knob 134 is rotatedsuch that the right slide 154 is urged distally and the left slide 156is urged proximally, the deflection wire 162 a connected to the rightslide 154 is placed into compression and the deflection wire 162 bconnected to the left slide 156 is placed into tension. In anembodiment, this causes the proximal segment 116, distal segment 114,and/or extreme distal end 126 of the catheter body 112 to deflect in afirst direction. Conversely, when the knob 134 is rotated such that theright slide 154 is urged proximally and the left slide 156 is urgeddistally, the deflection wire 162 a connected to the right slide 154 isplaced into tension and the deflection wire 162 b connected to the leftslide 156 is placed into compression. This causes the proximal segment116, distal segment 114, and/or extreme distal end 126 of the catheterbody 112 to deflect in a second direction that is opposite the firstdirection.

The control handle 118 of the present invention as described has severaladvantages. First, the handle 118 is compact and may be operated with asingle hand. Second, the threaded slides 154, 156 and knob 134 allow aphysician to make fine, controlled adjustments to the bend in the distalend 126 of the catheter body 112. Third, once the knob 134 is rotated soas to cause a bend in the distal end 126 of the catheter body 112, thethreads 184, 186, 190, 192 interact to maintain the bend withoutrequiring any action on the physician's part. Fourth, because the slides154, 156 simply displace distally and proximally along the longitudinalaxis of the handle 118, they are less likely to permanently deform thewires 38 as compared to the wire displacement mechanisms in some priorart handles. Fifth, the threads 184, 186, 190, 192 are mechanicallyadvantageous in that they provide increased deflection wire travel andreduced actuation effort for the physician, as compared to some priorart handles.

While FIGS. 16-20 depict an embodiment where the slides 154, 156 haveexternal threads 184, 186 and the knob 134 has internal threads 190,192, in other embodiments the threading arrangement is reversed. For adiscussion of one such embodiment, reference is made to FIGS. 21-23.FIG. 21 is a longitudinal sectional elevation of the handle 118 ₁ takenalong section line 21-21 of FIG. 15. FIG. 22 is a side elevation of anexemplary slide employed in the embodiment depicted in FIG. 21. FIG. 23is a longitudinal sectional elevation of the adjusting knob taken alongsection line 23-23 of FIG. 15.

A comparison of the embodiment depicted in FIGS. 21-23 to the embodimentdepicted in FIGS. 17, 19 and 20 reveals that the two embodiments aregenerally the same, except as will be described in the followingdiscussion of FIGS. 21-23. Reference numbers utilized in FIGS. 21-23pertain to the same or similar features identified by the same referencenumbers in FIGS. 17, 19 and 20, though successive embodiments offeatures are distinguished with subscript.

As shown in FIG. 21, the adjusting knob 134 ₁ is pivotally attached to amounting shaft (i.e., a slide base or base portion) 138 ₁ containedwithin the handle grip 136 ₁. A wire guide 150 ₁ is positioned withinthe adjusting knob 134 ₁. Like the embodiment depicted in FIG. 16, theembodiment illustrated in FIG. 21 includes a right slide or member 154 ₁and a left slide or member 156 ₁ that are slideably positioned within aslot (i.e., a slide compartment) 158 ₁ in the mounting shaft 138 ₁.

As can be understood from FIG. 22, the slides 154 ₁, 156 ₁, which aremirror images of each other, each have a rectangular box-like proximalportion 168 ₁ and a distal portion 172 ₁ that may be rectangular orhalf-cylindrical. Each proximal portion 168 ₁ has a generally planarouter sidewall and bottom wall. These planar surfaces slideably displaceagainst the generally planar sides and bottom of the slot 158 ₁, whichact as thrust surfaces for the slides 154 ₁, 156 ₁.

Each distal portion 172 ₁ is hollowed out to form half of a cylindricalpassage 164 ₁ that is created when the slides 154 ₁, 156 ₁ are abuttedagainst each other in a side-by-side relationship. Thus, each distalportion 172 ₁ of each slide 154 ₁, 156 ₁ includes an innercircumferential surface, which when combined with the innercircumferential surface of the other slide 154 ₁, 156 ₁, defines thecylindrical passage 164 ₁.

As indicated in FIG. 22, in one embodiment, the inner circumferentialsurface of the right slide 154 ₁ is threaded with a right-hand thread184 ₁. Similarly, as can be understood from FIG. 22, the innercircumferential surface of the left slide 156 ₁ is threaded with aleft-hand thread 186 ₁. Thus, the distal portion 172 ₁ of each slide 154₁, 156 ₁ is equipped with internal threads. In another embodiment, theinner circumferential surface of the right slide 154 ₁ is threaded witha left-hand thread 186 ₁. Similarly, the inner circumferential surfaceof the left slide 156 ₁ is threaded with a right-hand thread 184 ₁.

As indicated in FIG. 23, the knob 134 ₁ includes an outer hub 146 a ₁surrounding an inner hub 146 b ₁. A space 195 exists between, and isdefined by, the inner and outer hubs 146 a ₁, 146 b ₁. The space 195 isadapted to receive the distal ends 172 ₁ of each slide 154 ₁, 156 ₁. Theouter circumferential surface of the inner hub 146 b ₁ has both righthand threads 190 ₁ and left hand threads 192 ₁. These external threads190 ₁, 192 ₁ of the knob 134 ₁ mate with the corresponding internalthreads 184 ₁, 186 ₁ of the slides 154 ₁, 156 ₁. More specifically, theright external threads 190 ₁ of the knob 134 ₁ mate with the rightinternal threads 184 ₁ of the right slide 154 ₁, and the left externalthreads 192 ₁ of the knob 134 ₁ mate with the left internal threads 186₁ of the left slide 156 ₁.

As can be understood from FIG. 21, in one embodiment, as the knob 134 ₁is rotated clockwise relative to the longitudinal axis of the handle 118₁, the internal and external right threads 184 ₁, 190 ₁ engage and theinternal and external left threads 186 ₁, 192 ₁ engage, thereby causingsimultaneous opposed displacement of the right and left slides 154 ₁,156 ₁ longitudinally within the slot 158 ₁ in the handle 118 ₁.Specifically, because of the threading arrangement of the knob 134 ₁ andthe slides 154 ₁, 156 ₁, the right slide 154 ₁ moves distally within theslot 158 ₁ and the left slide 156 ₁ moves proximally within the slot 158₁ when the knob 134 ₁ is rotated clockwise relative to the handle grip136 ₁ of the handle 118 ₁. Conversely, when the knob 134 ₁ is rotated ina counterclockwise manner relative to the handle grip 136 ₁ of thehandle 118 ₁, the right slide 154 ₁ moves proximally within the slot 158₁ and the left slide 156 ₁ moves distally within the slot 158 ₁.

As can be understood from FIG. 21, when the knob 134 ₁ is rotated suchthat the right slide 154 ₁ is urged distally and the left slide 156 ₁ isurged proximally, the deflection wire 162 connected to the right slide154 ₁ is placed into compression and the deflection wire 162 connectedto the left slide 156 ₁ is placed into tension. This causes the extremedistal end 126 of the catheter body 112 to deflect in a first direction.Conversely, when the knob 134 ₁ is rotated such that the right slide 154₁ is urged proximally and the left slide 156 is urged distally, thedeflection wire 162 connected to the right slide 154 ₁ is placed intotension and the deflection wire 162 connected to the left slide 156 ₁ isplaced into compression. This causes the extreme distal end 126 of thecatheter body 112 to deflect in a second direction that is opposite thefirst direction.

For a detailed discussion of another embodiment of a catheter handle 118₂, reference is now made to FIGS. 24-26. FIG. 24 is a plan view of thehandle 118 ₂. FIG. 25 is a side elevation of the handle 118 ₂. FIG. 26is an isometric view of the distal end of the handle 118 ₂.

As shown in FIGS. 24-26, the handle 118 ₂ includes an adjusting knob 134₂ on its distal end and a handle grip 136 ₂ on its proximal end. As canbe understood from FIGS. 24-26, in one embodiment, the knob 134 ₂ has agenerally circular cross-section and the handle grip 136 ₂ has agenerally oval cross-section. In one embodiment, both the knob 134 ₂ andthe handle grip 136 ₂ have generally circular cross-sections. The ovalcross-section of the handle grip 136 ₂ is advantageous because itprovides the physician with a tactile indication of the catheter'srotational position.

For a more detailed discussion of the components of the handle 118 ₂,reference is now made to FIG. 27, which is a longitudinal sectional planview of the handle 118 ₂ taken along section line 27-27 of FIG. 26. Asshown in FIG. 27, an o-ring 148 ₂ is located between the handle grip 136₂ and a groove in the knob 134 ₂. The knob 134 ₂ is pivotally affixed tothe handle grip 136 ₂ via a rotating retaining-ring 189 that resideswithin grooves in both the knob and the handle grip 136 ₂.

As illustrated in FIG. 27, a catheter body-retaining nut 160 ₂ isthreadably affixed to the distal end of a wire guide 150 ₂ that extendsalong the axial center of the knob 134 ₂. As indicated in FIG. 27 andmore clearly shown in FIG. 28, which is a longitudinal sectional planview of the knob 134 ₂ taken along section line 28-28 in FIG. 26, acylindrical hole or shaft 188 ₂ passes through the knob 134 ₂ along theknob's longitudinal axis. The inner circumferential surface of the shaft188 ₂ has both right hand threads 190 ₂ and left hand threads 192 ₂ thatextend towards the distal end of the knob 134 ₂ from a hub portion 146 ₂of the knob 134 ₂. As shown in FIG. 28, in one embodiment, the knob 134₂ is a singular integral piece.

As indicated in FIG. 27, a right slide 154 ₂ and a left slide 156 ₂ arelongitudinally displaceable within the handle 118 ₂ and about theproximal end of the wire guide 150 ₂. As shown in FIGS. 29 and 30, whichare, respectively, a right side isometric view of the slides 154 ₂, 156₂ displaced about the wire guide 150 ₂ and a left side isometric view ofthe slides 154 ₂, 156 ₂ displaced about the wire guide 150 ₂, each slide154 ₂, 156 ₂ has a planar slide face 174 ₂ that abuts and slideablydisplaces against the slide face 174 ₂ of the opposed slide 154 ₂, 156₂. Also, each slide 154 ₂, 156 ₂ has a channel that combines with thechannel of the opposed slide 154 ₂, 156 ₂ to form a passage 164 ₂through which the proximal end of the wire guide 150 ₂ passes as theslides 154 ₂, 156 ₂ displace about the wire guide 150 ₂. As shown inFIG. 27, the passage 164 ₂ formed by the channels also provides apathway along which the deflection wires 162 a, 162 b (represented bydashed lines in FIG. 27) travel from a proximal portion of the slides154 ₂, 156 ₂, through the wire guide 150 ₂, and onward to the extremedistal end 126 of the catheter body 112.

As indicated in FIGS. 29 and 30, each slide 154 ₂, 156 ₂ has ahalf-cylinder distal portion 172 ₂ and a shorter and wider half-cylinderproximal portion 168 ₂. The right slide 154 ₂ has a right-handed thread184 ₂ on its distal portion 172 ₂. Similarly, the left slide 156 ₂ has aleft-handed thread 186 ₂ on its distal portion 172 ₂. Thus, as can beunderstood from FIG. 27, when the knob 134 ₂ is rotated in a clockwisedirection relative to the handle grip 136 ₂ the right handed threads 190₂ within the knob 134 ₂ engage the right handed threads 184 ₂ of theright slide 154 ₂, and the left handed threads 192 ₂ within the knob 134₂ engage the left handed threads 186 ₂ of the left slide 156 ₂. As aresult, the right slide 154 ₂ is distally displaced within the handle118 ₂ and the left slide 156 ₂ is proximally displaced within the handle118 ₂. Accordingly, the deflection wire 162 a attached to the rightslide 154 ₂ is pushed (i.e., subjected to a compressive force) and thedeflection wire 162 b attached to the left slide 156 ₂ is pulled (i.e.,subjected to a tension force). Conversely, if the knob is rotatedcounterclockwise, the opposite displacement of the slides 154 ₂, 156 ₂and deflection wires 162 a, 162 b will occur.

As indicated in FIG. 27, each deflection wire 162 a, 162 b is attachedto the proximal portion 168 ₂ of its respective slide 154 ₂, 156 ₂ viaretention screws 166 ₂. The retention screws, which are more clearlyillustrated in FIGS. 29 and 30, are threadably mounted in the proximalportions 168 ₂.

As shown in FIGS. 29 and 30, each half-cylindrical proximal portion 168₂ of a slide 154 ₂, 156 ₂ has an upper and lower planar notch 194adjacent their respective planar slide faces 174 ₂. The function ofthese notches 194 may be understood by referring to FIGS. 31 and 32.

FIG. 31 is a longitudinal section elevation of the handle grip 136 ₂taken along section line 31-31 in FIG. 24. FIG. 32 is a latitudinalsection elevation of the handle grip 136 ₂ taken along section line32-32 in FIG. 25. As shown in FIGS. 28 and 29, the handle grip 136 ₂ isone integral piece having an interior cylindrical void 196 in which theproximal portions 168 ₂ of the slides 154 ₂, 156 ₂ may displace asindicated in FIG. 27.

As shown in FIGS. 31 and 32, upper and lower ribs 198 extend from thewalls that form the interior cylindrical void 196. The ribs 198 runlongitudinally along a substantial portion of the cylindrical void'slength. As can be understood from FIGS. 29-32, the upper planar notches194 on the proximal portions 168 ₂ of the slides 154 ₂, 156 ₂ interfacewith, and displace along, the upper rib 198 as the slides 154 ₂, 156 ₂displace within the cylindrical void 196. Similarly, the lower planarnotches 194 on the proximal portions 168 ₂ of the slides 154 ₂, 156 ₂interface with, and displace along, the lower rib 198 as the slides 154₂, 156 ₂ displace within the cylindrical void 196. Thus, the ribs 198act as thrust surfaces for the slides 154 ₂, 156 ₂.

For a detailed discussion of another embodiment of the handle 118 ₂depicted in FIGS. 24-32, reference is now made to FIG. 33. FIG. 33 is anisometric view of the distal end of a control handle 118 ₃ for acatheter 110 ₂ wherein the handle 118 ₃ and catheter body 112 have athrough lumen 200. As shown in FIG. 33, in one embodiment, the lumen 200and the electrical wire tube 130, which extends to the electricalconnector 132, pass through strain reliefs 202 and into the proximal endof the handle grip 136 ₃. In one embodiment, the lumen 200 terminates atits proximal end with a stopcock 204. In one embodiment, the stopcock204 has a hemostasis seal 206 that can be utilized for guide wireinsertion. While a long flexible length of lumen 200, as depicted inFIG. 33, provides motion isolation while inserting contrast from asyringe, in one embodiment, the lumen 200 does not extend from thehandle grip 136 ₃. Instead, the stopcock 204 or luer fitting is simplyattached to the lumen 200 where it exits the proximal end of the handlegrip 136 ₃.

For a better understanding of the path of the lumen 200, reference isnow made to FIGS. 34-36. FIG. 34 is an isometric view of the slides 154₃, 156 ₃, the wire guide 150 ₃, the wire tubing 130, and the lumen 200illustrating the path the lumen 200 takes through the handle 118 ₃. FIG.35 is an elevation view of the extreme proximal end surfaces of theslides 154 ₃, 156 ₃ as viewed from arrow A in FIG. 34 and illustratingthe path the lumen 200 and wire tubing 130 take into the passage formedby the channels 164 ₃ of the slides 154 ₃, 156 ₃. FIG. 36 is anisometric view of the lumen 200, deflection wires 162 a, 162 b, andelectrical wires 208 of the wire tube 130 exiting the catheterbody-retaining nut 160 ₃ on the distal end of the handle 118 ₃.

As shown in FIGS. 34 and 35, the lumen 200 and the wire tubing 130 passthrough their respective reliefs 202 and into the passage formed by thechannels 164 ₃ in each slide 154 ₃, 156 ₃. In one embodiment, soon afterthe wire tubing 130 and the lumen 200 enter the passage 164 ₃, the wires208 of the wire tubing 130 exit the wire tubing 130 and are dispersedabout the outer circumference of the lumen 200 as depicted in FIG. 36.

As illustrated in FIG. 34, in another embodiment, after the wire tube130 and lumen 200 enter the passage 164 ₃, the wire tube 130 and thelumen 200 continue on their pathway to the distal end 126 of thecatheter body 112 by passing, in a side-by-side arrangement, through theremainder of the passage 164 ₃ formed into the slides 154 ₃, 156 ₃ andinto an internal passage that extends along the longitudinal axis of thewire guide 150 ₃. Near the end of the wire guide 150 ₃, the wire 208exists the wire tube 130. The wire 208, lumen 200 and deflection wires162 a, 162 b then pass into the catheter by exiting the catheterbody-retaining nut 160 ₃ of the handle as indicated in FIG. 36.

For a detailed discussion of another embodiment of the handle 118,reference is now made to FIG. 37, which is an isometric view of thehandle 118 ₄ exploded to show its various components. As can beunderstood from FIG. 37, the features of the handle 118 ₄ depicted inFIG. 37 are similar to the features of the handle 118 depicted in FIG.16, except the handle 118 ₄ depicted in FIG. 37 is configured to have arelatively large, generally uniform in diameter, pathway extend the fulllength of the handle 118 ₄ (i.e., from the distal opening 212 in thewire guide 150 ₄, through the passage 164 ₄ defined in the slides 154 ₄,156 ₄ and through an exit hole 214 in the proximal end of the shaft 138₂).

The configuration of the handle 118 ₄ that allows a relatively largegenerally uniform in diameter pathway to pass through the length of thehandle 118 ₄, as depicted in FIG. 37, is more clearly shown in FIG. 38,which is a longitudinal sectional elevation taken along section line38-38 in FIG. 37. As illustrated in FIG. 38, in one embodiment, thepathway 210, which includes the passage through the wire guide 150 ₄ andthe passage 164 ₄ through the slides 154 ₄, 156 ₄, is large enough thatthe catheter body 112 itself may pass through the pathway 210 and beconnected to the proximal end of the shaft 138 ₂ at the exit hole 214.Thus, in one embodiment, to prevent the catheter body 112 from rotatingwith the adjusting knob 134 ₄, the catheter body 112 is affixed to theshaft 138 ₂ at the exit hole 214. In one embodiment, the catheter body112 runs the full length of the handle 118 ₄ as depicted in FIG. 38,except the body 112 is affixed to the wire guide 150 ₄ at or near thedistal opening 212. In other embodiments, the catheter body 112 isaffixed to both the wire guide 150 ₄ at or near the distal opening 212and the shaft 138 ₂ at the exit hole 214.

As can be understood from FIG. 38 and as more clearly depicted in FIG.39, which is an isometric view of the slides 154 ₄, 156 ₄ oriented toshow their portions of the passage 164 ₄ and their planar slide faces174 ₃, the passage 164 ₄ is large enough in diameter to displace overthe outer diameter of the wire guide 150 ₄. As shown in FIGS. 38 and 39,a catheter body passage 218 passes through the proximal portion 168 ₄ ofeach slide 154 ₄, 156 ₄, thereby allowing the slides 154 ₄, 156 ₄ todisplace back and forth over the outer surface of the catheter body 112.

As indicated in FIG. 38, in one embodiment, the catheter body 112 has anopening 220 in its wall that allows the wires 162 to exit the body 112and connect to the slides 154 ₄, 156 ₄. In one embodiment, the wires 162connect to the slides 154 ₄, 156 ₄ via tension adjustment screws 180 ₁as previously discussed.

Due to the configuration of the slides 154 ₄, 156 ₄, the wire guide 150₄ and the shaft 138 ₂, the catheter body 112 may run uninterrupted thefull length of the handle 118 ₄. As a result, electrical wiring 208 (seeFIG. 36) and a lumen 200 may be routed the full length of the handle 118₄ by way of the body 112.

For a detailed discussion of another embodiment of the handle 118 of thepresent invention, reference is now made to FIGS. 40 and 41. FIG. 40 isan isometric view of the handle 118 ₅ exploded to show its variouscomponents. FIG. 41 is a longitudinal sectional elevation of the handle118 ₅ taken along section line 41-41 of FIG. 40. Generally speaking, thefeatures of the handle 118 ₅ depicted in FIGS. 40 and 41 are similar tothe features of the handle 118 ₄ depicted in FIG. 37, except the twoembodiments employ different slider arrangements. For example, theembodiments depicted in FIGS. 15-39 employ parallel slides or members154, 156 (i.e., the slides 154, 156 exist within the handle 118 in aparallel or side-by-side arrangement). As will be understood from FIGS.40 and 41 and the following Figures, in the embodiment of the handle 118₅ depicted in FIGS. 40 and 41, the slides or members 219, 221 existwithin the adjustment knob 134 ₅ in a series arrangement (i.e., theslides 219, 221 are not parallel or side-by-side to each other, but areoriented end-to-end along a longitudinal axis of the handle 118 ₅).

As shown in FIGS. 40 and 41, the adjusting knob 134 ₅ is pivotallycoupled to the distal end of the mounting shaft (i.e., base portion) 138₃. The wire guide 150 ₅ extends through the center of the adjusting knob134 ₅ and the mounting shaft 138 ₃. The catheter body 112 is coupled tothe distal end of the wire guide 150 ₅ and, in one embodiment, extendsthrough the wire guide 150 ₅ and out of the proximal end of the mountingshaft 138 ₃.

As shown in FIGS. 40 and 41, a distal slide 219 is located in a distalportion of the adjusting knob 134 ₅, and a proximal slide 221 is locatedin a proximal portion (i.e., hub portion 146 ₃) of the adjusting knob134 ₅. As illustrated in FIG. 41, the outer surface of each slide 219,221 has threads 222 that mate with threads 226 on an interior surface ofthe adjusting knob 134 ₅.

As illustrated in FIG. 41, each deflection wire 162 a, 162 b travelsalong the interior of the wire guide 150 ₅ until it exits the wire guide150 ₅ at a hole 228 in the sidewall of the wire guide 150 ₅. Eachdeflection wire 162 a, 162 b then extends to the slide 219, 221 to whichthe deflection wire 162 a, 162 b is attached. In one embodiment, inorder to attach to a slide 219, 221, a deflection wire 162 a, 162 bpasses through a passage 232 in the slide 219, 221 and attaches to ahollow tension adjustment screw 180 ₂ via a knot 178 ₁ as previouslydescribed.

For a better understanding of the orientation of the threads 222, 226,reference is now made to FIGS. 42 and 43. FIG. 42 is the samelongitudinal sectional elevation of the adjusting knob 134 ₅ as it isdepicted in FIG. 41, except the adjusting knob 134 ₅ is shown by itself.FIG. 43 is a side elevation of the slides 219, 221.

As shown in FIGS. 42 and 43, in one embodiment, the distal slide 219 hasright hand threads 222 that engage right hand threads 226 in the distalportion of the adjusting knob 134 ₅, and the proximal slide 221 has lefthand threads 222 that engage left hand threads 226 in the proximalportion of the adjusting knob 134 ₅. Thus, as can be understood fromFIGS. 40-43, when the adjusting knob 134 ₅ is rotated relative to themounting shaft 138 ₃ in a first direction about the longitudinal axis ofthe handle 118 ₅, the slides 219, 221 will converge along the wire guide150 ₅, thereby causing the first wire 162 to be placed into tension andthe second wire 162 to be compressed. As a result, the distal end 126 ofthe catheter body 112 will deflect in a first direction. Similarly, whenthe adjusting knob 134 ₅ is rotated in a second direction that isopposite from the first direction, the slides 219, 221 will divergealong the wire guide 150 ₅, thereby causing the first wire 162 to becompressed and the second wire 162 to be placed into tension. As aresult, the distal end 126 of the catheter body 112 will deflect in asecond direction generally opposite from the first direction.

In one embodiment, to prevent the slides 219, 221 from simply rotatingaround the wire guide 150 ₅ when the adjusting knob 134 ₅ is rotated,the slides 219, 221 and wire guide 150 ₅ are configured such that theslides 219, 221 will displace along the wire guide 150 ₅, but notrotationally around it. For example, as indicated in FIG. 44A, which isa latitudinal sectional elevation of the handle 118 ₅ as taken alongsection line 44A-B-44A-B in FIG. 41, the wire guide 150 ₅ has a squarecross section that mates with a square hole 238 running the length ofthe slide 219, 221. The interaction between the square hole 238 and thesquare cross section of the wire guide 150 ₅ prevents a slide 219, 221from rotating about the wire guide 150 ₅, but still allows the slide219, 221 to displace along the length of the wire guide 150 ₅.

In another embodiment, as shown in FIG. 44B, which is another embodimentof the same latitudinal sectional elevation depicted in FIG. 44A, eachslide 219, 221 has a hole 240 with a circular cross section. Each hole240 runs the length of its respective slide 219, 221 and includes a key234 that extends into the hole 240 from the interior circumferentialsurface of the hole 240. The key 234 engages a groove or slot 230 thatruns along the length of the wire guide 150 ₅ as depicted in FIG. 45,which is a side elevation of one embodiment of the wire guide 150 ₅. Theinteraction between the key 234 and the slot 230 prevents a slide 219,221 from rotating about the wire guide 150 ₅, but still allows the slide219, 221 to displace along the length of the wire guide 150 ₅.

As shown in FIGS. 44A and 44B, a hollow shaft 242 extends through thewire guide 150 ₅. This allows a catheter body 112 with a lumen to extendcompletely through the handle 118 ₅ as shown in FIG. 41.

For a detailed discussion of another embodiment of the handle 118 thatis similar to the embodiment depicted in FIG. 40, reference is now madeto FIGS. 46 and 47. FIG. 46 is a longitudinal sectional elevation of thehandle 118 ₆ as if taken through section line 46-46 of a handle similarto the handle 118 ₅ of FIG. 40. FIG. 47 is a longitudinal sectional planview of the handle 118 ₆ as if taken through section line 47-47 of ahandle similar to the handle 118 ₅ in FIG. 40 and wherein section line47-47 forms a plane that is perpendicular to the plane formed by sectionline 46-46 in FIG. 40.

As illustrated in FIGS. 46 and 47, the handle 118 ₆ includes anadjusting knob 134 ₆ pivotally coupled to the distal end of the mountingshaft (i.e., base portion) 138 ₄. In one embodiment, the adjusting knob134 ₆ includes a proximal end 244, a distal end 246 and a threaded shaft248, which is connected to the proximal end 244 and extends distallyalong the longitudinal axis of the adjusting knob 134 ₆. The threadedshaft 248 includes a distal end 250, a proximal end 252, a series ofright hand threads 254 along a distal portion of the shaft 248, and aseries of left hand threads 256 along a proximal portion of the shaft248.

As shown in FIGS. 46 and 47, a distal slide 219 ₁ is located in a distalportion of the adjusting knob 134 ₆, and a proximal slide 221 ₁ islocated in a proximal portion (i.e., a hub portion) of the adjustingknob 134 ₆. Each slide has a hole 224 through which the threaded shaft248 passes. The inner circumferential surface of the hole 224 for thedistal slide 219 ₁ has right hand threads that mate with the right handthreads 254 on the distal portion of the shaft 248. Similarly, the innercircumferential surface of the hole 224 for the proximal slide 221 ₁ hasleft hand threads that mate with the left hand threads 256 on theproximal portion of the shaft 248. In other embodiments, the locationsfor the left and right threads are reversed.

As can be understood from FIG. 48, which is an isometric view of oneembodiment of the wire guide 150 ₆, a hollow center shaft 258 extendsfrom the distal end of the wire guide 150 ₆, through the threaded shaft248 of the adjustment knob 134 ₆, and to the proximal end of the baseshaft 138 ₃. Thus, in one embodiment, a catheter body 112 may be routedthrough the lumen 242 of the wire guide's hollow center shaft 258 toexit the proximal end of the handle 118 ₆, as illustrated in FIGS. 46and 47.

As illustrated in FIG. 46, each deflection wire 162 a, 162 b travelsalong the interior of the wire guide 150 ₆ until it exits the wire guide150 ₆ at a hole 228 in the sidewall of the wire guide 150 ₆. Eachdeflection wire 162 a, 162 b then extends to the slide 219 ₁, 221 ₁ towhich the deflection wire 162 a, 162 b is attached. In one embodiment,in order to attach to a slide 219 ₁, 221 ₁, a deflection wire 162 a, 162b passes through a passage 232 in the slide 219 ₁, 221 ₁ and attaches toa hollow tension adjustment screw 180 ₃ via a knot 178 ₂ as previouslydescribed herein.

In one embodiment, as shown in FIG. 46, the deflection wire 162 bleading to the proximal slide 221 ₁ passes through a second passage 236in the distal slide 219 ₁. The second passage 236 has sufficientclearance that the passage 236 may easily displace along the wire 162 bwhen the distal slide 219 ₁ displaces distally and proximally. Thesecond passage 236 serves as a guide that stiffens the wire 162 b andhelps to reduce the likelihood that the wire 162 b will bend whencompressed.

As can be understood from FIGS. 46 and 47, when the adjusting knob 134 ₆is rotated relative to the mounting shaft 138 ₄ in a first directionabout the longitudinal axis of the handle 118 ₆, the slides 219 ₁, 221 ₁will converge along the threaded shaft 248, thereby causing the firstwire 162 a to be placed into tension and the second wire 162 b to becompressed. As a result, the distal end 126 of the catheter body 112will deflect in a first direction. Similarly, when the adjusting knob134 ₆ is rotated in a second direction that is opposite from the firstdirection, the slides 219 ₁, 221 ₁ will diverge along the threaded shaft248, thereby causing the first wire 162 a to be compressed and thesecond wire 162 b to be placed into tension. As a result, the distal end126 of the catheter body 112 will deflect in a second directiongenerally opposite from the first direction.

In one embodiment, to prevent the slides 219 ₁, 221 ₁ from simplyrotating with the threaded shaft 248 within the adjusting knob 134 ₆when the adjusting knob 134 ₆ is rotated, the slides 219 ₁, 221 ₁ andwire guide 150 ₆ are configured such that the slides 219 ₁, 221 ₁ willdisplace along the threaded shaft 248, but not rotationally within theadjusting knob 134 ₆. For example, as indicated in FIGS. 48 and 49,which is a latitudinal sectional elevation of the handle 118 ₆ as takenalong section line 49-49 in FIG. 46, the wire guide 150 ₆ has right andleft semicircular portions 260 that oppose each other and extend alongthe length of the hollow center shaft 258 of the wire guide 150 ₆. Asshown in FIG. 49, the generally planar opposed faces 262 of thesemicircular portions 260 abut against the generally planar side faces264 of the slides 219 ₁, 221 ₁. This interaction prevents a slide 219 ₁,221 ₁ from rotating within the adjustment knob 134 ₆ when the knob 134 ₆is rotated, but still allows the slide 219 ₁, 221 ₁ to displace alongthe length of the threaded shaft 248.

In still other embodiments shown in FIGS. 50-62, a multi-directionalcatheter control handle 266 may be used to maneuver the catheter body'sdistal end (or distal end portion or distal portion) into a variety oforientations, or to independently maneuver a distal segment and aproximal segment of a catheter shaft. The multi-directional cathetercontrol handle 266 may provide even further maneuverability incomparison to the embodiments discussed with reference to FIGS. 15-49.The multi-directional catheter control handle 266 enhancesmaneuverability of the catheter body's distal end through the use of afirst adjusting knob and a second adjusting knob, as opposed to oneadjusting knob.

Although the multi-directional handle 266 will be described in terms ofright/left (R/L) and anterior/posterior (A/P) deflection of a singlecatheter segment, application of the multi-directional handle 266 is notso limited. For example, as noted above, the multi-directional handle266 may also find use with a catheter shaft with twoindependently-deflectable segments. Accordingly, it should be understoodthat the following discussion contemplates a catheter shaft withindependently-deflectable segments, and descriptions of separate R/Ldeflection and A/P deflection also encompasses independent deflection ofdistal and proximal segments of a catheter shaft.

FIG. 50 shows one embodiment of the multi-directional catheter controlhandle 266 having a handle grip 268, an R/L adjusting knob 270, an A/Padjusting knob 272, and a longitudinal axis 274. With two adjustingknobs 270, 272, the multi-directional catheter control handle 266 maycontrol at least two pairs of deflection wires that in turn control theorientation of the catheter body's distal end.

FIG. 51, which has at least one component removed for purposes ofclarity, shows how four deflection wires 276 a through 276 d may beoriented about the lumen 200 adjacent to electrical wires 208. The fourdeflection wires 276 a through 276 d may be operably coupled to theadjusting knobs 270, 272 and to the catheter body's distal end or todistal and proximal segments of the catheter body. In one embodiment,for example, the R/L adjusting knob 270 may control the movement ofdeflection wires 276 a and 276 b, and the A/P adjusting knob 272 maycontrol the movement of deflection wires 276 c and 276 d. Rotating theR/L adjusting knob 270 thus deflects the distal end in right and leftdirections. Similarly, rotating the A/P adjusting knob 272 deflects thedistal end in anterior and posterior directions. Movement of the distalend is discussed in more detail below. However, in addition todeflection in four “cardinal” directions (i.e., right, left, anterior,and posterior), one skilled in the art will recognize that rotating theadjusting knobs 270, 272 in combination or in sequence may orient thedistal end at oblique angles in relation to the deflection wires 276and/or in relation to the rest of the flexible elongate member.Accordingly, the maneuverability of the catheter's distal end isenhanced.

The four deflection wires 276 a through 276 d may also be coupled toproximal and distal segments of the catheter shaft such as, for exampleonly, one of the embodiments illustrated in FIGS. 1-14. For example, inan embodiment, the deflection wires 276 a and 276 b may be coupled to aproximal segment of the catheter shaft, and deflection wires 276 c and276 d may be coupled to the distal segment of the catheter shaft. Insuch an embodiment, the A/P adjusting knob 272 may act as a distalsegment adjusting knob (i.e., a distal segment manual actuationmechanism) and the R/L adjusting knob 270 may act as a proximal segmentadjusting knob (i.e., a proximal segment manual actuation mechanism).The deflection wires 276 a through 276 d may extend through the cathetershaft as shown in any of FIGS. 1-14, or in some other manner known inthe art.

The components of one embodiment of the multi-directional cathetercontrol handle 266 that provide for enhanced maneuverability are shownin an exploded view in FIG. 52. These components can be categorized intothree non-mutually exclusive groups: a first group of components thathelp achieve both R/L catheter deflection and A/P catheter deflection, asecond group that is used primarily to achieve A/P catheter deflection,and a third group that is used primarily to achieve R/L, catheterdeflection. These groups merely facilitate discussion of themulti-directional catheter control handle 266 and by no means limit thefunctions, purposes, benefits, or the like of any given component. Also,particularly where users integrate R/L, deflection and A/P deflection,components from all of these groups are used to deflect the catheterbody's distal end.

The handle grip 268 is one such common component that is useful duringboth R/L and A/P deflection. The handle grip 268 is shown in twosubparts 268 a, 268 b and is located near the proximal end of themulti-directional catheter control handle 266. Forming the handle grip268 from two subparts 268 a, 268 b allows for quick access to internalcomponents, if needed. An end cap 278 and a clip feature 280 may helpretain the handle grip subparts 268 a, 268 b around a mounting shaft 284that acts as a support member for a number of components of the handle266. The end cap 278 may secure generally peripheral rims 286 a, 286 bextending from subparts 268 a, 268 b, respectively. The clip feature 280may be configured to mate with an internal rim 288 on subparts 268 a,268 b to further secure the handle grip 268 around the mounting shaft284.

In addition, a nozzle-like projection 290 may be helpful during both R/Land A/P deflection. The nozzle-like projection 290 may provide strainrelief for the flexible tubular body of a catheter that extends from theprojection 290. Moreover, the nozzle-like projection 290 may haveinternal threads that mate with threads on a wire guide, as discussedbelow.

FIG. 52 also shows components of the multi-directional catheter controlhandle 266 that allow for A/P deflection of the catheter body's distalend. In particular, the handle 266 may include a first slide 292 and asecond slide 294, which may resemble those slides shown in FIG. 18. Theslides 292, 294 may be mirror images of each other and may includeproximal portions 296 and distal portions 298. Deflection wires mayoperably attach to the proximal portions 296 of the first and secondslides 292, 294. For example, a pair of deflection wires 276 c, 276 d ofFIG. 51 may operably attach to the proximal portions 296 of the firstand second slides 292, 294. Hence translation of the first and secondslides 292, 294 may control the pair of deflection wires 276 c, 276 dand ultimately the catheter body's distal end, or a proximal segment ordistal segment of the catheter body.

The deflection wires may be operably attached to the proximal portions296 through a number of techniques including, for example, using aretention screw or soldering. In some embodiments, for example, theproximal portions 296 of the first and second slides 292, 294 may haveholes through which the deflection wires may slidably extend. Withregard to a single deflection wire, for example, a segment of thedeflection wire that protrudes proximally beyond one of the proximalportions 296 may be attached to a mass of solder that cannot passthrough a hole in the proximal portion 296. Translating the proximalportion 296 of a slide proximally from a “neutral position,” asdescribed further below, may translate the mass of solder and theattached deflection wire proximally. But when the proximal portion 296is translated distally from the neutral position, the slidably attacheddeflection wire and the mass of solder may remain largely stationary. Inthese embodiments, rotation of the corresponding adjusting knob altersthe tension in only one of the pair of deflection wires at a time. Someamount of slack in one of a pair of deflection wires can be advantageouswhere the distal end of the catheter is maneuvered into a variety oforientations using both the R/L adjusting knob 270 and the A/P adjustingknob 272.

Moreover, the distal portion 298 of the first slide 292 may containright-handed square threads, while the distal portion 298 of the secondslide 294 may contain left-handed square threads. By configuring theslides 292, 294 with square threads, the slides 292, 294 do not, or atleast are less likely to, revert after displacement. Square threads havea self-locking property that makes them less susceptible to threadslippage or back-out. Similar to the slides shown in FIG. 29, the slides292, 294 may be hollowed so as to form a passage 300 for various wiresof the catheter including, for example, the lumen and deflection wires276. And further, the slides 292, 294 may be positioned within themounting shaft 284 such that they may translate, but are prevented fromrotating due to the contours of their proximal portions 296 and themounting shaft 284.

To translate the first and second slides 292, 294, an adjusting knobinsert 302 with square internal threading may be provided. The adjustingknob insert 302 may be rotatably coupled to the mounting shaft 284 byinserting a hub portion 304 of the insert 302 into a distal opening 306of the mounting shaft 284. A dowel pin 308 may be inserted into anangular pinhole 310 to secure a groove 312 on the hub portion 304. Oncerotatably coupled, the adjusting knob insert 302 may rotate about thelongitudinal axis 274, but is prevented from translating along thelength of the mounting shaft 284. The adjusting knob insert 302 may haveright-handed and left-handed internal threads similar to those shown inFIG. 28, except that the threads in the insert 302 may be squarethreads. Thus, the distal portions 298 of the first and second slides292, 294 may be inserted within the adjusting knob insert 302, with theinternal threads of the insert 302 engaging with the external threads,or parts thereof, of the slides 292, 294.

When the adjusting knob insert 302 rotates one way, the first slide 292may translate in a direction opposite the second slide 294. When theadjusting knob insert 302 rotates the other way, each slide 292, 294 maytranslate, respectively, in a reverse direction. This back and forthtranslation of the slides 292, 294 is one aspect of the catheter handle266 that allows for A/P deflection.

Still referring to FIG. 52, the multi-directional catheter controlhandle 266 may also include a wire guide 314 positioned within theadjusting knob insert 302 and the passage 300 formed by the first andsecond slides 292, 294. To prevent the wire guide 314 from rotating whenthe adjusting knob insert 302 rotates, the wire guide 314 may haveprojections 316 that can be inserted within slots 318 within the firstand second slides 292, 294. Because the first and second slides 292, 294do not rotate relative to the mounting shaft 284, neither does the wireguide 314 once the projections 316 are inserted within the slots 318.Further, at least one washer and a retaining ring 320 may hold a distalend (not shown) of the wire guide 314 in place within the adjusting knobinsert 302. The distal end of the wire guide 314 may be threaded toallow for engagement with internal threads disposed in the nozzle-likeprojection 290. Yet further, the A/P adjusting knob 272 may bepress-fitted onto a distal portion 322 of the adjusting knob insert 302.The A/P adjusting knob 272 may provide a more effective contact surfacefor a user of the handle 266 as opposed to the adjusting knob insert 302itself. In an alternative embodiment, the A/P adjusting knob 272 may beintegral with the distal portion 322 of the adjusting knob insert 302such that the A/P adjusting knob 272 need not be press-fitted onto thedistal portion 322. In either case, internal threads may be said to bedisposed within the A/P adjusting knob 272.

In addition, FIG. 52 shows components of the multi-directional cathetercontrol handle 266 that allow for R/L deflection of the catheter body'sdistal end. In particular, a right slide 324 and a left slide 326 may beprovided. The right slide 324 may include a proximal tab 328 thatextends through a slot 330 in the mounting shaft 284 when a flat portion332 of the right slide 324 is positioned against the mounting shaft 284.Once positioned, the right slide 324 and the proximal tab 328 maytranslate along a portion of the length of the mounting shaft 284. Theright slide 324 may further include a set of right-hand square threads334 for engagement with internal threads (not shown) of the R/L,adjusting knob 270. Similar to the square threads on the first andsecond slides 292, 294, the square threads 334 on the right slide 324prevent, or at least reduce the likelihood of, thread slippage orback-out.

Similar to the right slide 324, the left slide 326 may also include aproximal tab 336 that extends through a slot 338 in the mounting shaft284 when a flat portion 340 of the left slide 326 is positioned againstthe mounting shaft 284. Once positioned, the left slide 326 and theproximal tab 336 may also translate proximally and distally in relationto the mounting shaft 284. When both right and left slides 324, 326 arepositioned against the mounting shaft 284, the proximal tab 336 of theleft slide 326 may sit below the proximal tab 328 of the right slide324. Similarly, the left slide 326 may also include a set of left-handsquare threads 342 for engagement with internal threads of the R/Ladjusting knob 270. Hence the R/L adjusting knob 270 may haveright-handed and left-handed internal threads similar to those shown inFIG. 28, except that the threads in the R/L, adjusting knob 270 may besquare threads. Rotating the R/L, adjusting knob 270 about thelongitudinal axis 274 may cause the right and left slides 324, 326 totranslate in opposite directions along the length of the handle 266.

The proximal tabs 328, 336 may provide points of attachment fordeflection wires, such as the pair of deflection wires 276 a, 276 bshown in FIG. 51, for example. Just like the first and second slides292, 294, deflection wires may be attached to the proximal tabs 328, 336through a number of techniques including, for example, using a retentionscrew or soldering. Hence when the R/L adjusting knob 270 translates theright and left slides 324, 326 in opposite directions, a tensile forceon at least one of the two attached deflection wires—different thanthose controlled by the A/P adjusting knob 272—is either increased ordecreased.

It should be noted that although the terms “first,” “second,” “right,”“left,” “R/L,” and “A/P” are used herein, such terms are merely for thebenefit of this detailed description. Hence the first and second slidescould be referred to as a first pair of slide members, for example, andthe right and left slides could be referred to as a second pair of slidemembers. Likewise, the same can be said for the adjusting knobs,deflection wires, and so on. Moreover, some embodiments of themulti-directional catheter control handle may operate without two pairsof slide members. Rather, two slide members may be used. By way ofexample, a first slide member may be operably coupled to a first pair ofdeflection wires and to one adjusting knob, while a second slide membermay be operably coupled to a second pair of deflection wires and toanother adjusting knob. One exemplary way a single slide member couldcontrol a pair of deflection wires is to attach the deflection wires toopposite sides of the slide member. Attaching the slide member at apoint between the opposite sides to a pivot would allow for conversemovement of the attached deflection wires.

Once the right and left slides 324, 326 are positioned alongside themounting shaft 284, the R/L, adjusting knob 270 may be rotatably coupledto the mounting shaft 284. In one embodiment, the R/L, adjusting knob270 may be assembled around the right and left slides 324, 326 and themounting shaft 284. The internal threads of the R/L, adjusting knob 270may engage or partially engage the right-hand and left-hand squarethreads 334, 342. To keep the R/L adjusting knob 270 from translatingalong the mounting shaft 284, stop blocks 344 may be inserted throughapertures 346 in the R/L adjusting knob 270 and openings 348 in themounting shaft 284. As such, the stop blocks 344 may ride along thesurface of the hub portion 304 of the adjusting knob insert 302. Morespecifically, the stop blocks 344 may be positioned in a ring groove(not shown) disposed within the R/L adjusting knob 270 such that the R/Ladjusting knob 270 may rotate about the mounting shaft 284, but isprevented from translating along the length of the mounting shaft 284.In other words, the stop blocks 344 may extend away from the hub portion304 and into a ring groove within the R/L adjusting knob 270, but thestop blocks 344 do not occupy the apertures 346 of the R/L, adjustingknob 270. To cover the apertures 346 and prevent contaminants fromentering the handle 266, caps 350 may be placed over the apertures 346.

In one embodiment, the multi-directional catheter control handle 266 mayalso include at least one deflection stop pin 352, which may extendfully or partially within the mounting shaft 284. Deflection stop pins352 may be positioned between the proximal portions 296 of the first andsecond slides 292, 294 and the proximal tabs 328, 336 of the right andleft slides 324, 326. The deflection stop pins 352 may prevent theslides 292, 294, 324, 326 from being over-displaced so as to strain,stretch, deform, break, or otherwise damage one of the deflection wires.Accordingly, when at least one of the slides 292, 294, 324, 326 contactsthe deflection stop pins 352, one or both of the pairs of deflectionwires may be fully deflected and thus the adjusting knobs 272, 270 maynot be rotated further in that direction. In another embodiment, thestop pins 352 may limit the movement of only the first and second slides292, 294.

Referring now to FIG. 53, components of one embodiment of themulti-directional catheter control handle 266 are shown in a state ofsub-assembly. Namely, the mounting shaft 284, the first and secondslides 292, 294, and the adjusting knob insert 302 are shown to bepartially assembled. The hub portion 304 of the adjusting knob insert302 may extend through the distal opening 306 of the mounting shaft 284.The dowel pin 308, however, has not yet been inserted. The distalportion 298 of the second slide 294 has been fully inserted within theadjusting knob insert 302, with the proximal portion 296 of the secondslide 294 protruding. With the second slide 294 fully inserted into theadjusting knob insert 302, the first slide 292 may be inserted into theadjusting knob insert 302. As the adjusting knob insert 302 is rotatedwithin the mounting shaft 284, the second slide 294 is backed out of theadjusting knob insert 302 and the first slide 292 is drawn into theadjusting knob insert 302. The slides 292, 294 translate in oppositedirections due to the right-hand square threads on the first slide 292,the left-hand square threads on the second slide 294, and the right- andleft-hand internal threading within the adjusting knob insert 302.

The second slide 294 may be backed out of the adjusting knob insertuntil it is generally even with the first slide 292, as shown in FIG.54. The first and second slides 292, 294 come to a neutral positionwhere they are equally inserted within the adjusting knob insert 302.This position is neutral because from this point each slide 292, 294 canmove an equal distance proximal to or distal from the adjusting knobinsert 302. This means that each slide 292, 294 can cause an attacheddeflection wire to deflect the catheter body's distal end to the samedegree, albeit in opposing directions.

FIG. 54 shows one embodiment of the mounting shaft 284 in a state ofsub-assembly similar to that of FIG. 53. In FIG. 54, though, the rightand left slides 324, 326 are shown alongside the mounting shaft 284.Further, the proximal tabs 328, 336 of the right and left slides 324,326 are shown extending through the slots 330, 338 in the mounting shaft284. The right slide 324 is shown to be offset from the left slide 326because the R/L adjusting knob 270 may be assembled around the right andleft slides 324, 326 much like the adjusting knob insert 302 isassembled around the first and second slides 292, 294.

As can be understood from FIG. 55, the R/L adjusting knob 270 may bepositioned around the mounting shaft 284. To secure the R/L, adjustingknob 270, the stop blocks may be inserted through the apertures in theR/L adjusting knob 270 and openings in the mounting shaft 284. Once thecaps 350 are placed over the apertures, the right and left slides 324,326 may be positioned within the R/L, adjusting knob 270. Like the firstand second slides 292, 294, the right and left slides 324, 326 may alsobe brought to a neutral position. There, each slide 324, 326 may extendgenerally equally within the R/L adjusting knob 270, and one proximaltab 328 may be positioned over the other proximal tab 336, as shown inFIG. 55.

FIG. 55 also illustrates the catheter body 112 extending through thelength of a partially-assembled multi-directional catheter controlhandle 266. This portion of the catheter body 112 that may extendthrough, or generally couple to, the multi-directional catheter controlhandle 266 or the mounting shaft 284 can be referred to as the proximalend of the catheter body 112. Specifically, the proximal end of thecatheter body 112 may extend through the clip feature 280, between theproximal tabs 328, 336, through the gap 300 formed by the first andsecond slides 292, 294, and through the adjusting knob insert 302. Asdiscussed with reference to the embodiments shown in FIGS. 15-49, theproximal end of the catheter body 112 may have various openings ordiscontinuities to allow deflection wires into the catheter body 112.The deflection wire 276 a, which may be attached to the proximal tab328, may extend along the outside of the proximal end of the catheterbody 112 and into the passage 300 formed by the first and second slides292, 294. The deflection wire 276 a and other deflection wires (notshown) may enter the proximal end at one or more discontinuities in thecatheter body 112, as described above.

Now referring to FIG. 56, the wire guide 314 may be positioned aroundthe catheter body 112, with the end of the wire guide 314 having theprojections 316 being placed into the distal portion 322 of theadjusting knob insert 302. The wire guide 314 may slide into theadjusting knob insert 302 such that the projections 316 slide into theslots in the first and second slides. Ultimately, the distal end 356 ofthe wire guide 314 may be positioned within the distal portion 322 ofthe adjusting knob insert 302. To secure the distal end 356, the atleast one washer and retaining ring (not shown) may be used to maintainthe distal end 356 within the distal portion 322 of the adjusting knobinsert 302. In a final assembly, threads 358 of the distal end 356 mayengage with internal threads on the nozzle-like projection to furtherretain the components of the handle 266.

FIG. 57 shows one embodiment of the multi-directional catheter controlhandle 266 in which the handle grip is removed for purposes of clarity.Moreover, the embodiment shown in FIG. 57 utilizes many of thecomponents that were discussed with reference to FIGS. 37-39. Bycontrast, however, the embodiment shown here includes two adjustingknobs 270, 272 and the right and left slides, 324, 326. This embodimentexemplifies how some of the embodiments discussed with reference toFIGS. 15-49, or at least the components contained therein, may beadapted for use with the multi-directional catheter control handle 266.Moreover, FIG. 58 shows the same embodiment as that in FIG. 57, exceptthat the handle grip and the R/L adjusting knob are removed for anadditional perspective.

Although the multi-directional catheter control handle is describedherein for use with a catheter body, such a handle could be used inconjunction with any medical device or flexible elongate member, even inapplications beyond the medical field. Moreover, the multi-directionalcatheter control handle may be compatible with virtually all of theembodiments discussed with reference to FIGS. 15-49. For example,electrodes may be disposed along the catheter body or along the distalportion of the catheter body for delivering therapy, performing ablativeprocedures, mapping internal organs, and the like.

With reference to FIGS. 59A-59E and corresponding FIGS. 60A-60E, thecatheter body's distal end 126 is shown in a variety of orientationsthat are caused by the multi-directional catheter control handle. FIGS.59A-59E show side views of the distal end 126, while FIGS. 60A-60E showcorresponding top views of the distal end 126. FIGS. 59A, 60A show thedistal end 126 in a straight, undeflected position 390. Here, althoughnot shown, both the first and second slides and the right and leftslides may be in neutral positions. As a user rotates the R/L adjustingknob, the right and left slides translate in opposite directions, withone of the slides pulling a deflection wire (e.g., deflection wire 276 ain FIG. 51) away from the distal end 126. The result of this tension inthe deflection wire is shown in FIGS. 59B, 60B, with the distal end 126deflected to the right 392. From there, the user may rotate the A/Padjusting knob to cause the first and second slides to translate inopposite directions. Similarly, one of the first or second slides maypull a deflection wire (e.g., deflection wire 276 c in FIG. 51) awayfrom the distal end 126. FIGS. 59C, 60C show the result of thissequence, with the distal end 126 deflected in a posterior direction394. To progress to a deflection 396 shown in FIGS. 59D, 60D, the usermay deflect the R/L adjusting knob in a direction opposite that whichwas used to initially deflect the distal end 126. As such, the right andleft slides may respectively translate in directions opposite thosetaken to arrive at the orientation shown in FIGS. 59B, 60B. With thedistal end 126 now deflected to the left 396, the user may rotate theA/P adjusting knob in a different direction to arrive at an anteriordeflection 398 shown in FIGS. 59E, 60E.

Without reiterating the full sequence taken to achieve the variousdeflections shown in FIGS. 59A-5E, 60A-60E, similar steps may be takento achieve the deflections shown in FIGS. 61A-61E, 62A-62E. FIGS.61A-61E show side views of the distal end 126, while FIGS. 62A-62E showcorresponding top views of the distal end 126. FIGS. 61A, 62A show thedistal end 126 in the straight, undeflected position 390. The primarydifference between FIGS. 59B-59E, 60B-60E and FIGS. 61B-61E, 62B-62E isthat the distal end 126 shown in FIGS. 61B-61E, 62B-62E is deflectedfurther than the distal end 126 shown in FIGS. 59B-59E, 60B-60E. Insteadof approximately 90 degree states of deflection, the distal end 126 isshown to be in approximately 180 degree states of deflection. Thus,FIGS. 61B, 62B show the distal end 126 in a rightward deflection 400;FIGS. 61C, 62C show an anterior deflection 402; FIGS. 61D, 62D show aleftward deflection 404; and FIGS. 61E, 62E show a posterior deflection406. Although the adjusting knobs 270, 272 may need to be rotatedfurther to deflect the distal end 126 to 180 degrees, a similar sequenceof rotations of the adjusting knobs 270, 272 may be used to achieve eachdeflection.

One skilled in the art will understand that the distal end 126 iscapable of deflection at all different angles under the control of themulti-directional catheter control handle. For example, the distal end126 may be held at a position between FIG. 59D and FIG. 61E, or thedistal end 126 may be deflected less than 90 degrees or greater than 180degrees. Thus FIGS. 59-62 show merely exemplary embodiments of thedistal end 126.

Furthermore, one skilled in the art will understand that amulti-directional catheter control handle may be combined with differentcatheter shaft configurations and constructions to create catheters withvarious numbers and configurations of deflectable segments. For example,a multi-directional catheter control handle may be combined with anembodiment of a catheter shaft, such as one of the embodiments shown inFIGS. 6-12, and may be used to effect the shaft deflections shown inFIGS. 6-9.

One skilled in the art will also understand how deflecting the distalend (or distal portion) of the catheter may be accomplished withstructures other than those described and depicted above. For example,if push/pull deflection wires (sometimes referred to astension/compression wires) are employed, a first and second pair ofdeflection wires may not be necessary. Rather, a first deflection wireand a second deflection wire could be positioned 90 degrees apart aboutthe lumen, similar to two (e.g., 276 a, 276 d) of the four generallyorthogonal-configured pairs of wires shown in FIG. 51. Since eachpush/pull deflection wire can carry tensile and compressive loads, thereis no need to pair each deflection wire with an additional, opposingdeflection wire.

In still another embodiment, the multi-directional catheter controlhandle could function without adjusting knobs. Instead, the slidemembers could have protrusions that extend from the mounting shaft. Auser could use the protrusions to translate, or axially displace, theslides within the mounting shaft. In yet another embodiment, themulti-directional handle could use adjusting knobs that rotate at thesurface of the mounting shaft or handle grip. For example, one adjustingknob operatively connected (e.g., through a gear system) to one pair ofslides could be placed on the top of the handle such that it does notrotate about a longitudinal axis of the handle. Another adjusting knoboperatively connected to another pair of slides could be placed on theside of the handle. Thus, the two adjusting knobs could be positioned at90 degrees from one another. Moreover, the adjusting knob on the top ofthe handle could control R/L deflection while the adjusting knob on theside of the handle could control A/P deflection. This configurationcould enhance the intuitiveness of the handle, as rotating the topadjusting knob clockwise and counterclockwise would deflect the distalportion of the catheter right and left, and rotating the side adjustingknob forward and backward would deflect the distal portion of thecatheter posterior and anterior. Each of the above-described adjustingknobs and protrusions are encompassed in the term “manual actuationmechanism,” though a manual actuation mechanism is not limited to suchknobs and protrusions.

Even further, the present disclosure contemplates an embodiment wherethe degree of rotation of the adjusting knobs can be made to besubstantially similar to the degree of deflection in the distal portionof the catheter. For example, rotating a R/L adjusting knob 90 degreesto the right may cause the distal portion of the catheter to deflectabout 90 degrees to the right. This characteristic may be accomplishedby using proper thread angles, gear ratios, or the like.

The aforementioned catheter handles may operate with a variety ofcatheter systems such as visualization systems, mapping systems, andnavigation support and positioning systems (i.e., for determining aposition and orientation (P&O) of a flexible elongate member or othermedical device). For example, the catheter handles may be used with anENSITE™ VELOCITY™ system running a version of NAVX™ softwarecommercially available from St. Jude Medical, Inc., of St. Paul, Minn.and as also seen generally by reference to U.S. Pat. No. 7,263,397entitled “METHOD AND APPARATUS FOR CATHETER NAVIGATION AND LOCATION ANDMAPPING IN THE HEART” to Hauck et al., owned by the common assignee ofthe present disclosure, and hereby incorporated by reference in itsentirety. These exemplary systems with which the catheter handles may beutilized can comprise conventional apparatus known generally in the art,for example, the ENSITE™ VELOCITY™ system described above or other knowntechnologies for locating/navigating a catheter in space (and forvisualization), including for example, the CARTO™ visualization andlocation system of Biosense Webster, Inc., (e.g., as exemplified by U.S.Pat. No. 6,690,963 entitled “System for Determining the Location andOrientation of an Invasive Medical Instrument” hereby incorporated byreference in its entirety), the AURORA™ system of Northern Digital Inc.,a magnetic field based localization system such as the GMPS™ systembased on technology from MediGuide Ltd. of Haifa, Israel and now ownedby St. Jude Medical, Inc. (e.g., as exemplified by U.S. Pat. Nos.7,386,339, 7,197,354 and 6,233,476, all of which are hereby incorporatedby reference in their entireties) or a hybrid magnetic field-impedancebased system, such as the CARTO 3 visualization and location system ofBiosense Webster, Inc. (e.g., as exemplified by U.S. Pat. No. 7,848,789,which is hereby incorporated by reference in its entirety). Some of thelocalization, navigation and/or visualization systems can involveproviding a sensor for producing signals indicative of catheter locationand/or distal portion orientation information, and can include, forexample one or more electrodes in the case of an impedance-basedlocalization system such as the ENSITE™ VELOCITY™ system running NAVX™software, which electrodes can already exist in some instances, oralternatively, one or more coils (i.e., wire windings) configured todetect one or more characteristics of a low-strength magnetic field, forexample, in the case of a magnetic-field based localization system suchas the GMPS™ system using technology from MediGuide Ltd. describedabove.

Although a number of embodiments of this invention have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this invention. For example, alljoinder references (e.g., attached, coupled, connected, and the like)are to be construed broadly and may include intermediate members betweena connection of elements and relative movement between elements. Assuch, joinder references do not necessarily infer that two elements aredirectly connected and in fixed relation to each other. It is intendedthat all matter contained in the above description or shown in theaccompanying drawings shall be interpreted as illustrative only and notlimiting. Changes in detail or structure may be made without departingfrom the spirit of the invention as defined in the appended claims.

What is claimed is:
 1. An elongate medical device, comprising: anelongate shaft extending along a shaft longitudinal axis and comprisinga proximal shaft section and a distal shaft deflectable section,wherein: a proximal location of the distal shaft deflectable sectiondefines: a proximal deflection wire lumen in a proximal wall of thedistal shaft deflectable section through which a proximal deflectionwire extends; and a central lumen through which a distal deflection wireextends; and a distal location of the distal shaft deflectable sectiondefines a distal deflection wire lumen in a distal wall of the distalshaft deflectable section through which the distal deflection wireextends.
 2. The elongate medical device of claim 1, wherein the proximaldeflection wire is attached to a proximal deflection wire pull ring andthe distal deflection wire is attached to a distal deflection wire pullring.
 3. The elongate medical device of claim 1, wherein the proximaldeflection wire pull ring is disposed in the proximal wall of the distalshaft deflectable section and the distal deflection wire pull ring isdisposed in the distal wall of the distal shaft deflectable section. 4.The elongate medical device of claim 1, wherein the proximal location ofthe distal shaft deflectable section defines a proximal outer diameterand the distal location of the distal shaft deflectable section definesa distal outer diameter, and wherein the proximal outer diameter islarger than the distal outer diameter.
 5. The elongate medical device ofclaim 1, wherein the distal location of the distal shaft deflectablesection defines a distal shaft segment lumen, and wherein the distalshaft segment lumen and the central lumen have substantially equaldiameters.
 6. The elongate medical device of claim 1, wherein: theproximal deflection wire includes two proximal deflection wiresrespectively extending through two proximal deflection wire lumens; andthe distal deflection wire includes two distal deflections wiresextending through the central lumen.
 7. The elongate medical device ofclaim 6, wherein the two proximal deflection wires are configured todeflect a proximal shaft segment of the distal shaft deflectable sectionin two different proximal directions and the two distal deflection wiresare configured to deflect a distal shaft segment of the distal shaftdeflectable section in two different distal directions.
 8. The elongatemedical device of claim 7, wherein the two different proximal directionsare different than the two different distal directions.
 9. The elongatemedical device of claim 7, wherein the two different proximal directionsare the same as the two different distal directions.
 10. A method ofmanufacturing a catheter shaft, the method comprising: providing a firstshaft portion defining a longitudinal axis, the first shaft portioncomprising a first deflection element that is embedded in or otherwiserigidly coupled with the first shaft portion; placing a second shaftportion over the first shaft portion to create a catheter shaftassembly; and melt processing the catheter shaft assembly to join thesecond shaft portion to the first shaft portion.
 11. The method of claim10, further comprising placing a second deflection element radiallybetween the first shaft portion and the second shaft portion.
 12. Themethod of claim 11, wherein the second deflection element comprises apull ring disposed about the first shaft portion.
 13. The method ofclaim 11, wherein placing the second deflection element radially betweenthe first shaft portion and the second shaft portion comprises placingthe second deflection element proximal of the first deflection element.14. The method of claim 11, further comprising coupling a deflectionwire to the second deflection element.
 15. The method of claim 10, thefirst shaft portion defining a wall, the first shaft portion furthercomprising a deflection wire, the deflection wire being coupled to thefirst deflection element and extending through the wall.
 16. The methodof claim 10, wherein the first shaft portion has a distal end and thesecond shaft portion has a distal end, further wherein placing thesecond shaft portion over the first shaft portion to create the cathetershaft assembly comprises placing the second shaft portion so that thedistal end of the second shaft portion is proximal of the distal end ofthe first shaft portion.
 17. A method of manufacturing a catheter shaft,the method comprising: providing a first shaft portion defining alongitudinal axis, the first shaft portion comprising a first deflectionelement that is embedded in or otherwise rigidly coupled with the firstshaft portion; placing a second shaft portion over the first shaftportion to create a catheter shaft assembly, the second shaft portionbeing shorter longitudinally than the first shaft portion; and rigidlycoupling the second shaft portion to the first shaft portion.
 18. Themethod of claim 17, wherein a distal tip of the first shaft portion isdistal of a distal tip of the second shaft portion.
 19. The method ofclaim 17, wherein the first deflection element is distal of a distal tipof the second shaft portion.
 20. The method of claim 17, furthercomprising coupling a rounded tip element to a distal tip of at leastone of the first shaft portion and the second shaft portion.